1 unchanged sentence
CONSOLIDATED BALANCE SHEETS
−Removed: September 30,
+Added: and cash equivalents
+Added: in Eton Pharmaceuticals
+Added: receivable, net
+Added: expenses and other current assets
current assets
−Removed: Cash and cash equivalents
−Removed: Investment in Eton Pharmaceuticals
−Removed: Accounts receivable, net
−Removed: Prepaid expenses and other current assets
−Removed: Total current assets
−Removed: Property, plant and equipment, net
−Removed: Capitalized software costs, net
−Removed: Deferred financing costs
−Removed: Operating lease right-of-use assets, net
−Removed: Intangible assets, net
+Added: plant and equipment, net
+Added: software costs, net
+Added: lease right-of-use assets, net
$ 295,536,000
$ 313,174,000
−Removed: LIABILITIES AND STOCKHOLDERS’ EQUITY
+Added: AND STOCKHOLDERS’ EQUITY
+Added: payable and accrued expenses
+Added: rebates and copay assistance
+Added: payroll and related liabilities
+Added: revenue and customer deposits
+Added: portion of operating lease obligations
current liabilities
−Removed: Accounts payable and accrued expenses
−Removed: Accrued payroll and related liabilities
−Removed: Deferred revenue and customer deposits
−Removed: Current portion of operating lease obligations
−Removed: Total current liabilities
−Removed: Operating lease obligations, net of current portion
−Removed: Accrued expenses, net of current portion
−Removed: Notes payable, net of unamortized debt discount
−Removed: TOTAL LIABILITIES
−Removed: Commitments and contingencies
−Removed: STOCKHOLDERS’ EQUITY
−Removed: Common stock, $ 0.001 par value, 50,000,000 shares authorized, 35,117,621 and 29,901,530
−Removed: shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
−Removed: Additional paid-in capital
−Removed: Accumulated deficit
+Added: lease obligations, net of current portion
+Added: expenses, net of current portion
+Added: payable, net of unamortized debt discount
+Added: and contingencies
+Added: STOCKHOLDERS’
+Added: stock, $ 0.001 par value, 50,000,000 shares authorized, 35,380,955 and 35,168,260 shares issued and outstanding at March 31, 2024
+Added: and December 31, 2023, respectively
+Added: paid-in capital
( 147,469,000 )
( 133,904,000 )
−Removed: TOTAL HARROW, INC.
STOCKHOLDERS’ EQUITY
−Removed: Noncontrolling interests
−Removed: TOTAL STOCKHOLDERS’ EQUITY
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
+Added: Noncontrolling
+Added: STOCKHOLDERS’ EQUITY
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 295,536,000
$ 313,174,000
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: accompanying notes are an integral part of these condensed consolidated financial statements
+Added: UNAUDITED CONDENSED
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
Product sales, net
4 unchanged sentences
( 8,271,000 )
−Removed: ( 28,338,000 )
−Removed: ( 19,218,000 )
Operating expenses:
2 unchanged sentences
Total operating expenses
−Removed: Income (loss) from operations
+Added: (Loss)income from operations
+Added: ( 6,928,000 )
Other (expense) income:
2 unchanged sentences
( 4,747,000 )
−Removed: ( 16,200,000 )
−Removed: ( 5,386,000 )
−Removed: Equity in losses of unconsolidated entities
−Removed: ( 3,504,000 )
−Removed: ( 9,036,000 )
−Removed: Investment gain (loss) from Eton Pharmaceuticals
−Removed: ( 1,031,000 )
+Added: Investment (loss) gain from Eton Pharmaceuticals
( 1,248,000 )
1 unchanged sentence
( 5,465,000 )
−Removed: Other expense, net
+Added: Other income, net
Total other expense, net
1 unchanged sentence
( 8,141,000 )
−Removed: ( 19,333,000 )
−Removed: ( 18,763,000 )
−Removed: Loss before income taxes
−Removed: ( 2,852,000 )
−Removed: ( 6,429,000 )
−Removed: ( 14,027,000 )
−Removed: ( 15,066,000 )
−Removed: Income tax expense
−Removed: ( 1,539,000 )
−Removed: ( 1,236,000 )
−Removed: Net loss attributable to Harrow, Inc.
+Added: Loss before income tax expense
( 13,565,000 )
( 6,931,000 )
+Added: Income tax benefit
( 13,565,000 )
1 unchanged sentence
Basic and diluted net loss per share of common stock
−Removed: Weighted average number of shares of common stock outstanding, basic and diluted
−Removed: accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
−Removed: the periods ended September 30, 2023 and 2022
+Added: Weighted average number of shares of common stock outstanding, basic and
+Added: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
+Added: For the Three Months Ended March 31, 2024 and 2023
Noncontrolling
6 unchanged sentences
Issuance of common stock in connection with:
−Removed: Exercise of consultant stock-based options
Exercise of employee stock-based options
5 unchanged sentences
( 6,643,000 )
−Removed: Balance at September 30, 2022
−Removed: $ 111,738,000
−Removed: $ ( 110,548,000 )
−Removed: $ ( 355,000 )
−Removed: Balance at December 31, 2022
−Removed: $ 137,058,000
−Removed: $ ( 109,493,000 )
−Removed: $ ( 355,000 )
−Removed: Issuance of common stock in connection with:
−Removed: Public offering, net of offering costs
−Removed: Exercise of consultant stock-based options
−Removed: Exercise of employee stock-based options
−Removed: Vesting of RSUs and PSUs
−Removed: Shares withheld related to net share settlement of equity awards
−Removed: ( 12,970,000 )
−Removed: ( 12,971,000 )
−Removed: ( 12,971,000 )
−Removed: Stock-based compensation expense
−Removed: ( 15,263,000 )
−Removed: ( 15,263,000 )
−Removed: ( 15,263,000 )
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2023
$ 137,989,000
4 unchanged sentences
Stockholders’
−Removed: Balance at June 30, 2022
−Removed: $ 109,806,000
−Removed: $ ( 104,084,000 )
−Removed: $ ( 355,000 )
−Removed: Issuance of common stock in connection with:
−Removed: Exercise of consultant stock-based options
−Removed: Exercise of employee stock-based options
−Removed: Stock-based compensation expense
−Removed: ( 6,464,000 )
−Removed: ( 6,464,000 )
−Removed: ( 6,464,000 )
−Removed: Balance at September 30, 2022
+Added: Balance at December 31, 2023
$ 204,635,000
1 unchanged sentence
$ ( 355,000 )
−Removed: Balance at June 30, 2023
$ 204,635,000
2 unchanged sentences
Issuance of common stock in connection with:
−Removed: Public offering, net of offering costs
Exercise of employee stock-based options
−Removed: Vesting of PSUs
+Added: Vesting of RSUs
Shares withheld related to net share settlement of equity awards
6 unchanged sentences
( 13,565,000 )
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2024
$ 207,995,000
1 unchanged sentence
$ ( 355,000 )
+Added: $ 207,995,000
+Added: $ ( 147,469,000 )
+Added: $ ( 355,000 )
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: For the Nine Months Ended
−Removed: September 30,
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: For the Three Months Ended
CASH FLOWS FROM OPERATING ACTIVITIES
1 unchanged sentence
$ ( 6,643,000 )
−Removed: Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization of property, plant and equipment and software development costs
1 unchanged sentence
Amortization of operating lease right-of-use assets
−Removed: Provision for credit losses
+Added: (Recovery of) provision for credit losses
Amortization of debt issuance costs and debt discount
−Removed: Investment (gain) loss from investment in Eton
+Added: Investment loss (gain) from investment in Eton
( 2,042,000 )
−Removed: Equity in losses of unconsolidated entities
Loss on extinguishment of debt
−Removed: Loss on disposal of intangible assets
Stock-based compensation
+Added: Deferred income tax
Changes in assets and liabilities:
2 unchanged sentences
( 2,552,000 )
−Removed: ( 2,383,000 )
−Removed: ( 1,066,000 )
Prepaid expenses and other current assets
+Added: Accounts payable, accrued expenses, accrued rebates and copay assistance
( 8,939,000 )
−Removed: Accounts payable and accrued expenses
Accrued payroll and related liabilities
+Added: ( 1,111,000 )
Deferred revenue and customer deposits
−Removed: NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES
+Added: NET CASH USED IN OPERATING ACTIVITIES
( 4,628,000 )
+Added: ( 8,214,000 )
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in patent and trademark assets
−Removed: Purchase of product NDAs, marketing authorizations and patents
+Added: Purchase of product NDAs and related patents
( 130,474,000 )
Purchases of property, plant and equipment
−Removed: ( 1,266,000 )
−Removed: ( 1,719,000 )
NET CASH USED IN INVESTING ACTIVITIES
( 130,970,000 )
−Removed: ( 1,738,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
9 unchanged sentences
( 59,750,000 )
−Removed: Proceeds from public offering of common stock, net of costs
−Removed: Payments on finance lease obligations
−Removed: NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES
+Added: NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES
NET CHANGE IN CASH AND CASH EQUIVALENTS
( 5,547,000 )
+Added: ( 77,022,000 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
−Removed: CASH AND CASH EQUIVALENTS, end of period
+Added: CASH AND CASH EQUIVALENTS AT END OF PERIOD
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
4 unchanged sentences
Accrual of exit fee related to Oaktree Loan
−Removed: Insurance premium financed
−Removed: Purchase of intangible asset included in accounts payable and accrued expenses
−Removed: Purchase of property, plant and equipment included in accounts payable and accrued
+Added: Purchase of property, plant and equipment included in
+Added: accounts payable and accrued expenses
Right-of-use assets obtained in exchange for new operating lease obligations
−Removed: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: Income taxes owed for exercise of options
+Added: Insurance premium financed
+Added: accompanying notes are an integral part of these unaudited condensed consolidated financial statements
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: the Three and Nine Months Ended September 30, 2023 and 2022
+Added: the Three Months Ended March 31, 2024 and 2023
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
14 unchanged sentences
Harrow also owns royalty rights in various drug candidates being developed by Surface
−Removed: September 29, 2023, the Company changed its corporate name from Harrow Health, Inc.
−Removed: to Harrow, Inc.
−Removed: pursuant to a Certificate of Amendment
−Removed: to the Company’s Amended and Restated Certificate of Incorporation filed with the Secretary of State of the State of Delaware.
of Presentation
7 unchanged sentences
adjustments) considered necessary for a fair presentation have been included.
−Removed: Operating results for the three and nine months ended September
+Added: Operating results for the three months ended March 31,
2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other period.
11 unchanged sentences
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: following represents an update for the three and nine months ended September 30, 2023 to the significant accounting policies described
−Removed: in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
+Added: following represents an update for the three months ended March 31, 2024 to the significant accounting policies described in the Company’s
+Added: Annual Report on Form 10-K for the year ended December 31, 2023.
Uncertainties and Liquidity
4 unchanged sentences
of operations.
−Removed: Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables.
−Removed: Management considers historical collection rates, the current financial status of the Company’s customers, macroeconomic factors,
−Removed: and other industry-specific factors when evaluating for current expected credit losses.
−Removed: Forward-looking information is also considered
−Removed: in the evaluation of current expected credit losses.
−Removed: However, because of the short time to the expected receipt of accounts receivable,
−Removed: management believes that the carrying value, net of expected losses, approximates fair value and therefore, relies more on historical
−Removed: and current analysis of such financial instruments, including its trade receivables.
−Removed: determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of
−Removed: customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based
−Removed: on the type and industry in which they operate, mainly in the pharmaceuticals industry.
−Removed: Each business component is analyzed for estimated
−Removed: credit losses individually.
−Removed: In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts
−Removed: receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available.
−Removed: Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current
−Removed: expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such
−Removed: economic and industry-specific factors.
−Removed: Also, specific allowance amounts are established based on review of outstanding invoices to record
−Removed: the appropriate provision for customers that have a higher probability of default.
−Removed: accounts receivable balance on the Company’s condensed consolidated balance sheet as of September 30, 2023 was $ 18,468,000 , net
−Removed: of $ 108,000 of allowances.
−Removed: The following table provides a roll-forward of the allowance for credit losses that is deducted from the amortized
−Removed: cost basis of accounts receivable to present the net amount expected to be collected at September 30, 2023:
−Removed: OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
−Removed: Balance at January 1, 2023
−Removed: Change in expected credit losses
−Removed: Write-offs, net of recoveries
−Removed: Balance at September 30, 2023
−Removed: Combinations and Asset Acquisitions
−Removed: Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as
−Removed: a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross
−Removed: assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.
−Removed: If the screen is met, the transaction
−Removed: is accounted for as an asset acquisition.
−Removed: If the screen is not met, further determination is required as to whether the Company has acquired
−Removed: inputs, process, and output, which would meet the requirements of a business.
−Removed: If determined to be a business combination, the Company
−Removed: accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”)
−Removed: Accounting Standards Codification (“ASC”).
−Removed: 805, Business Combinations , requires the acquiring entity in a business combination to recognize the fair value of all assets
−Removed: acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value
−Removed: measurement point.
−Removed: Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including any
−Removed: contingent assets and liabilities, and any non-controlling interest in the acquiree based on the fair value estimates as of the date
−Removed: of acquisition.
−Removed: The Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration
−Removed: paid over the fair value of the identified net assets acquired.
−Removed: consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a
−Removed: particular event or events.
−Removed: The obligation for such contingent consideration payments are recorded at fair value on the acquisition date.
−Removed: The contingent consideration obligations are then evaluated each reporting period.
−Removed: Changes in the fair value of contingent consideration,
−Removed: other than changes due to payments, would be recognized as a gain or loss and recorded in the condensed consolidated statement of operations.
−Removed: determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, Business Combinations – Related
−Removed: Issues , which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on
−Removed: the cost to the acquiring entity or a relative fair value basis, which includes transaction costs in addition to consideration given.
−Removed: No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from
−Removed: the assets’ carrying amounts on the acquiring entity’s financial statements.
−Removed: Consideration transferred that is non-cash will
−Removed: be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of
−Removed: the assets acquired, and liabilities assumed, whichever is more clearly evident and more reliably measurable.
−Removed: Goodwill is not recognized
−Removed: in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable
−Removed: assets based on relative fair values.
Value Measurements
16 unchanged sentences
would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
−Removed: September 30, 2023 and December 31, 2022, the Company measured its investment in Eton Pharmaceuticals, Inc.
−Removed: (“Eton”) on a
−Removed: recurring basis.
−Removed: The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market
−Removed: prices in active markets for the same securities.
−Removed: As of September 30, 2023 and December 31, 2022, the fair market value of the Company’s
−Removed: investment in Eton was $ 8,265,000 and $ 5,589,000 , respectively.
+Added: March 31, 2024 and December 31, 2023, the Company measured its investment in Eton Pharmaceuticals, Inc.
+Added: (“Eton”) on a recurring
+Added: The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in
+Added: active markets for the same securities.
+Added: As of March 31, 2024 and December 31, 2023, the fair market value of the Company’s investment
+Added: in Eton was $ 7,433,000 and $ 8,681,000 , respectively.
+Added: The Company sold its remaining interest in April 2024 (see Note 16).
Company’s 2026 Notes (as defined in Note 11) are carried at face value, including the unamortized premium, less unamortized debt
7 unchanged sentences
following table presents the estimated fair values and the carrying values:
−Removed: SCHEDULE OF ESTIMATED FAIR VALUE
−Removed: September 30, 2023
+Added: OF ESTIMATED FAIR VALUE
+Added: March 31, 2024
December 31, 2023
15 unchanged sentences
shares (using the treasury stock method) from stock options, unvested RSUs, unvested PSUs and warrants were 4,318,057 and 4,750,340 at
−Removed: September 30, 2023 and 2022, respectively, and are excluded in the calculation of diluted net loss per common share for the periods presented,
+Added: March 31, 2024 and 2023, respectively, and are excluded in the calculation of diluted net loss per common share for the periods presented,
because the effect is anti-dilutive.
2 unchanged sentences
The number of shares underlying
−Removed: vested RSUs at September 30, 2023 and 2022 was 244,352 and 303,454 , respectively.
−Removed: following table shows the computation of basic net loss per share of common stock for the three and nine months ended September 30, 2023
−Removed: SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
−Removed: For the Three Months Ended September 30,
−Removed: For the Nine Months Ended September 30,
+Added: vested RSUs at March 31, 2024 and 2023 was 223,928 and 336,264 , respectively.
+Added: following table shows the computation of basic net loss per share of common stock for the three months ended March 31, 2024 and 2023:
+Added: OF BASIC NET LOSS PER SHARE OF COMMON STOCK
+Added: For the Three Months Ended
Numerator – net loss
1 unchanged sentence
$ ( 6,643,000 )
−Removed: $ ( 15,263,000 )
−Removed: $ ( 15,141,000 )
Denominator – weighted average number of shares outstanding, basic and diluted
Net loss per share, basic and diluted
−Removed: Company’s effective tax rate was ( 8.81 ) % and ( 0.50 ) % for the nine months ended September 30, 2023 and 2022, respectively.
+Added: Company’s effective tax rate was ( 0.11 )% and 4.16 % for the three months ended March 31, 2024 and 2023, respectively.
The Company’s
−Removed: effective tax rate for the nine months ended September 30, 2023 and 2022 differs from the U.S.
−Removed: federal statutory tax rate of 21 % due
−Removed: to state taxes, permanent book-tax differences related to Internal Revenue Code of 1986, as amended (“IRC”), Section 162(m)
+Added: effective tax rate for the three months ended March 31, 2024 and 2023 differs from the U.S.
+Added: federal statutory tax rate of 21 % due to
+Added: state taxes, permanent book-tax differences related to Internal Revenue Code of 1986, as amended (“IRC”), Section 162(m)
excess officer compensation limitation and share-based compensation and the change in valuation allowance.
−Removed: Company’s effective tax rate was ( 53.96 ) % and ( 0.54 ) % for the three months ended September 30, 2023, and 2022, respectively.
−Removed: Company’s effective tax rate for the three months ended September 30, 2023, and 2022 differs from the U.S.
−Removed: federal statutory tax
−Removed: rate of 21 % due to state taxes, permanent book-tax differences related to IRC Section 162(m) excess officer compensation limitation and
−Removed: share-based compensation and change in valuation allowance.
−Removed: of September 30, 2023 and December 31, 2022, there were no unrecognized tax benefits included in the condensed consolidated balance sheets
+Added: of March 31, 2024 and December 31, 2023, there were no unrecognized tax benefits included in the condensed consolidated balance sheets
that would, if recognized, affect the effective tax rate.
−Removed: in Eton Pharmaceuticals, Inc .
−Removed: of September 30, 2023, the Company owned 1,982,000 shares of Eton common stock (representing less than 10 % of the equity interests of
−Removed: Eton as of such date).
−Removed: At September 30, 2023, the fair market value of Eton’s common stock was $ 4.17 per share.
−Removed: In accordance with
−Removed: ASC 321, Investments — Equity Securities , the Company recorded unrealized holding gains (losses) from its Eton common stock
−Removed: position of $ 1,348,000 and $ 2,676,000 during the three and nine months ended September 30, 2023, respectively, and $ ( 1,031,000 ) and $ ( 4,341,000 )
−Removed: during the same periods in 2022, respectively, related to the change in fair market value of its investment in Eton during the measurement
−Removed: As of September 30, 2023, the fair market value of the Company’s investment in Eton was $ 8,265,000 .
in Melt Pharmaceuticals, Inc.
– Related Party
−Removed: of September 30, 2023, the Company owns 3,500,000 shares of common stock of Melt (representing approximately 36 % of the equity interests
−Removed: of Melt as of such date).
−Removed: The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position
−Removed: of variable interests in Melt.
−Removed: The Company has determined that it does not have the ability to control Melt, however it has the ability
−Removed: to exercise significant influence over the operating and financial decisions of Melt and uses the equity method of accounting for this
−Removed: Under this method, the Company recognizes earnings and losses in Melt in its condensed consolidated financial statements
−Removed: and adjusts the carrying amount of its investment in Melt accordingly.
−Removed: Any intra-entity profits and losses are eliminated.
−Removed: year ended December 31, 2021, the Company reduced the carrying value of its common stock investment in Melt to $ 0 as a result of the
−Removed: Company recording its share of equity losses in Melt since its deconsolidation in 2019.
−Removed: As of September 30, 2023, and at the time of
−Removed: entering into the Melt Loan Agreement (see Note 5), the Company owned 100 % of Melt’s indebtedness.
−Removed: Following the reduction of the
−Removed: carrying value of the Company’s common stock investment in Melt to $ 0 , the Company began recording 100 % of the equity method losses
−Removed: of Melt, based on its ownership of Melt’s total indebtedness.
−Removed: In addition, the Company treats interest paid in kind on the Melt
−Removed: Loan Agreement as an in-substance capital contribution and reduces its investment in Melt accordingly, rather than recording interest
−Removed: The Company has no other requirements to advance funds to Melt.
−Removed: following table summarizes the Company’s investments in Melt as of September 30, 2023:
+Added: Company owns 3,500,000
+Added: shares of common stock and 2,334,256
+Added: shares of preferred stock of Melt (representing in aggregate approximately 46 %
+Added: of Melt’s equity interests as of March 31, 2024).
+Added: The Company analyzes its investment in Melt and related agreements on a
+Added: regular basis to evaluate its position of variable interests in Melt.
+Added: The Company has determined that it does not have the ability
+Added: to control Melt, however it has the ability to exercise significant influence over the operating and financial decisions of Melt and
+Added: uses the equity method of accounting for this investment.
+Added: Under this method, the Company recognizes its portion of earnings and
+Added: losses in Melt in its consolidated financial statements and adjusts the carrying amount of its investment in Melt accordingly.
+Added: intra-entity profits and losses are eliminated.
+Added: a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
+Added: investments may be other than temporarily impaired.
+Added: Indicators include financial condition, operating performance, and near-term prospects
+Added: of the investee.
+Added: To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate both quantitative
+Added: and qualitative factors to determine if the loss in value is other than temporary.
+Added: If a potential loss in value is determined to be other
+Added: than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity method investments.
+Added: Company has no other investments other than its common stock and preferred stock positions in Melt and no other requirements to advance
+Added: funds to Melt.
+Added: following table summarizes the Company’s investments in Melt as of March 31, 2024:
SCHEDULE OF INVESTMENT
Share of Equity Method
−Removed: In-substance Capital
−Removed: Contributions
$ ( 5,810,000 )
−Removed: Note receivable
−Removed: ( 13,500,000 )
−Removed: ( 4,265,000 )
+Added: Preferred stock
( 18,397,000 )
1 unchanged sentence
Note 4 for more information and related party disclosure regarding Melt.
−Removed: in Surface Ophthalmics, Inc.
−Removed: – Related Party
−Removed: of September 30, 2023, the Company owned 3,500,000 common shares of Surface (representing approximately 20 % of the equity interests of
−Removed: Surface as of such date) and uses the equity method of accounting for this investment, as management has determined that the Company
−Removed: has the ability to exercise significant influence over the operating and financial decisions of Surface.
−Removed: Under this method, the Company
−Removed: recognizes earnings and losses in Surface in its condensed consolidated financial statements and adjusts the carrying amount of its investment
−Removed: in Surface accordingly.
−Removed: The Company’s share of earnings and losses are based on the Company’s ownership interest of Surface.
−Removed: Any intra-entity profits and losses are eliminated.
−Removed: During the year ended December 31, 2021, the Company reduced its common stock investment
−Removed: in Surface to $ 0 as a result of the Company recording its share of equity losses of Surface.
−Removed: The Company has no other investments in
−Removed: Surface and no other requirements to advance funds to Surface.
−Removed: following table summarizes the Company’s investment in Surface as of September 30, 2023:
−Removed: SCHEDULE OF INVESTMENT
−Removed: Share of Equity
−Removed: Method Losses
−Removed: $ ( 5,320,000 )
−Removed: Note 6 for more information and related party disclosure regarding Surface.
−Removed: Adopted Accounting Pronouncements
−Removed: September 2016, FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments .
−Removed: This ASU replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and
−Removed: requires consideration of a broader range of reasonable and supportable information for credit loss estimates on certain types of financial
−Removed: instruments, including trade receivables.
−Removed: In addition, new disclosures are required.
−Removed: The ASU, as subsequently amended, is effective for
−Removed: the Company for the fiscal years beginning after December 15, 2022.
−Removed: The Company adopted ASU 2016-13 on January 1, 2023.
−Removed: composition of the Company’s accounts receivable, investment portfolio, and other financial assets, including current market conditions
−Removed: and historical credit loss activity, the adoption of this standard did not have a material impact on the Company’s consolidated
−Removed: financial statements or disclosures.
−Removed: Specifically, the Company’s estimate of expected credit losses as of September 30, 2023, using
−Removed: its expected credit loss evaluation process described above, resulted in no adjustments to the provision for credit losses and no cumulative-effect
−Removed: adjustment to accumulated deficit on the adoption date of the standard.
−Removed: Guidance Issued but Not Adopted at September 30, 2023
−Removed: August 2023, FASB issued ASU 2023-05, Business Combinations—Joint Venture Formations (Subtopic 805-60):
−Removed: Recognition and Initial
−Removed: Measurement , which applies to the formation of entities that meet the definition of a joint venture (or a corporate joint venture)
−Removed: and requires joint ventures to initially measure all contributions received upon formation at fair value.
−Removed: The new guidance does not impact
−Removed: accounting by the venturers.
−Removed: The new guidance is applicable to joint venture entities with a formation date on or after January 1, 2025
−Removed: on a prospective basis.
−Removed: Joint ventures formed prior to the effective date may elect to apply the new guidance retrospectively back to
−Removed: their original formation date.
−Removed: We will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the definition
−Removed: of a joint venture.
−Removed: Company accounts for contracts with customers in accordance with ASC 606, Revenue from Contracts with Customers .
−Removed: The Company has
−Removed: three primary streams of revenue:
−Removed: (1) revenue recognized from sales of products through its pharmacy and outsourcing facility and sales
−Removed: of branded products to wholesalers through a third-party logistics (“3PL”) partner, (2) revenue recognized from a commission
−Removed: agreement with a third party, and (3) revenue recognized from intellectual property licenses and asset purchase agreements.
+Added: Guidance Issued but Not Adopted at March 31, 2024
+Added: August 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-05,
+Added: Business Combinations—Joint Venture Formations (Subtopic 805-60):
+Added: Recognition and Initial Measurement , which applies to
+Added: the formation of entities that meet the definition of a joint venture (or a corporate joint venture) and requires joint ventures to initially
+Added: measure all contributions received upon formation at fair value.
+Added: The new guidance does not impact accounting by the venturers.
+Added: guidance is applicable to joint venture entities with a formation date on or after January 1, 2025 on a prospective basis.
+Added: Joint ventures
+Added: formed prior to the effective date may elect to apply the new guidance retrospectively back to their original formation date.
+Added: will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the definition of a joint venture.
+Added: October 2023, FASB issued ASU 2023-06, Disclosure Improvements—Codification Amendments in Response to the SEC’s Disclosure
+Added: Update and Simplification Initiative .
+Added: This ASU modifies the disclosure or presentation requirements of a variety of topics in the
+Added: codification by aligning them with the SEC’s regulations.
+Added: The amendments to the various topics should be applied prospectively,
+Added: and the effective date for the Company for each amendment will be determined based on the effective date of the SEC’s removal of
+Added: the related disclosure from Regulation S-X or Regulation S-K.
+Added: If the SEC has not removed the applicable requirement by June 30, 2027,
+Added: then the related amendment in ASU 2023-06 will be removed from the codification and will not become effective.
+Added: Early adoption of this
+Added: ASU is prohibited.
+Added: The Company does not expect the amendments in this ASU to have a material impact on the disclosures or presentation
+Added: in its consolidated financial statements.
+Added: November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures , which
+Added: enhances the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements.
+Added: ASU 2023-07 is effective for the Company in our annual reporting for fiscal 2024 and for interim period reporting beginning in fiscal
+Added: 2025 on a retrospective basis, with all required disclosures to be made for all prior periods presented in the consolidated financial
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of ASU 2023-07 on its consolidated financial
+Added: December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures , which enhances the
+Added: disclosures required for income taxes in the Company’s annual consolidated financial statements.
+Added: Notably, this ASU requires entities
+Added: to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that
+Added: meet a quantitative threshold.
+Added: ASU 2023-09 is effective for the Company in its annual reporting for fiscal year 2025 on a prospective
+Added: Early adoption and retrospective reporting are permitted.
+Added: The Company is currently evaluating the impact of ASU 2023-09 on its
+Added: consolidated financial statements.
+Added: Reclassifications
+Added: prior period items and amounts have been reclassified to conform to the classifications used to prepare the condensed consolidated financial
+Added: statements for the current period.
+Added: These reclassifications had no material impact on the Company’s condensed consolidated financial
+Added: position, results of operations, or cash flows as previously reported.
+Added: Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers .
+Added: has three primary streams of revenue:
+Added: (1) product revenues, including revenue recognized from sales of products through its pharmacy
+Added: and outsourcing facility and sales of branded products to wholesalers through a third-party logistics (“3PL”) partner, (2)
+Added: revenue recognized from transfer of acquired product sales and profits in 2023, and (3) revenue recognized from intellectual property
+Added: licenses and related arrangements.
Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner.
22 unchanged sentences
The transaction price is based on an amount that reflects the consideration to which the Company expects
−Removed: to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales
−Removed: deductions) and an estimate for returns and replacements established at the time of sale.
−Removed: The Company utilizes the services of a
−Removed: third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products.
−Removed: of promised goods is satisfied within a year, and therefore there are no significant financing components.
−Removed: There is no non-cash consideration
−Removed: related to product sales.
+Added: to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts, copay assistance and other deductions (collectively,
+Added: sales deductions) and an estimate for returns and replacements established at the time of sale.
+Added: The Company utilizes the services
+Added: of a third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products.
+Added: transfer of promised goods is satisfied within a year, and therefore there are no significant financing components.
+Added: There is no non-cash
+Added: consideration related to product sales.
the transaction price to the performance obligations in the contract:
6 unchanged sentences
occurs at delivery.
−Removed: Company had entered into an agreement whereby it was paid a fee calculated based on sales the Company generates from a pharmaceutical
−Removed: product that is owned by a third party.
−Removed: The revenue earned from this arrangement was recognized, at which point there was no future performance
−Removed: obligation required by the Company and no consequential continuing involvement on the Company’s part to recognize the associated
From Transfer of Acquired Product Sales and Profits
11 unchanged sentences
The estimated
−Removed: Chargebacks are recorded as a reduction in revenues from transfer of acquired product sales and profits in the Company’s condensed
−Removed: consolidated statements of operations, and recorded as a reduction to accounts receivable in the condensed consolidated balance sheets,
−Removed: at the time the revenue is recognized.
−Removed: Property License Revenues
−Removed: Company currently holds five intellectual property licenses and related agreements pursuant to which the Company has agreed to license
−Removed: or sell to a customer with the right to access the Company’s intellectual property.
+Added: Chargebacks are recorded as a reduction in revenues from transfer of acquired product sales and profits in the Company’s consolidated
+Added: statements of operations, and recorded as a reduction to accounts receivable in the consolidated balance sheets, at the time the revenue
+Added: is recognized.
+Added: Property License and Related Arrangements Revenues
+Added: of March 31, 2024, the Company holds five intellectual property licenses and related arrangements pursuant to which the Company has agreed
+Added: to license or sell to a customer the right to access the Company’s intellectual property.
License arrangements may consist of non-refundable
19 unchanged sentences
recognized on a straight-line basis over the applicable term.
−Removed: disaggregated by revenue source for the three and nine months ended September 30, 2023 and 2022 consisted of the following:
+Added: disaggregated by revenue source for the three months ended March 31, 2024 and 2023 consisted of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
Product sales, net
−Removed: Commission revenues
−Removed: Transfer of acquired product sales/profit
+Added: Other revenues (including transfer of acquired product sales/profit)
Total revenues
−Removed: revenue and customer deposits at September 30, 2023 and December 31, 2022 were $ 153,000 and $ 113,000 , respectively.
−Removed: All deferred revenue
−Removed: and customer deposit amounts at December 31, 2022 were recognized as revenue during the nine months ended September 30, 2023.
−Removed: RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES
−Removed: of VEVYE TM U.S.
−Removed: and Canadian Commercial Rights
−Removed: July 2023, the Company acquired commercial rights of VEVYE (cyclosporine ophthalmic solution) 0.1 %, an ophthalmic drug product, for the
−Removed: and Canadian markets (the “VEVYE Acquisition”).
−Removed: The Company acquired the commercial rights to VEVYE by entering into
−Removed: a license agreement with Novaliq GmbH (“Novaliq”).
−Removed: As consideration, the Company made initial payments to Novaliq totaling
−Removed: $ 8,000,000 and will pay low double-digit royalties on net sales of VEVYE along with potential commercial milestone payments.
−Removed: Company accounted for the VEVYE Acquisition as an acquisition of assets and capitalized the initial payments of $ 8,000,000 and costs
−Removed: of $ 70,000 associated with the transaction.
−Removed: of Certain U.S.
−Removed: and Canadian Commercial Rights to Santen and Eyevance Products
−Removed: July 2023, the Company entered into an Asset Purchase Agreement with Eyevance Pharmaceuticals, LLC and a License Agreement with Santen
−Removed: (collectively, the “Santen Agreements”), each a subsidiary of Santen Pharmaceuticals Co., Ltd.
−Removed: (collectively, “Santen”).
−Removed: Pursuant to the Santen Agreements, the Company acquired the exclusive commercial rights to assets associated with the following ophthalmic
−Removed: products (collectively, the “Santen Products”):
−Removed: FLAREX, NATACYN, ZERVIATE, VERKAZIA and FRESHKOTE in the US, and VERKAZIA
−Removed: and CATIONORM PLUS in Canada.
−Removed: transactions pursuant to the Santen Agreements are referred to in these notes as the “Santen Products Acquisition.”
−Removed: the terms of the Santen Agreements, the Company made an initial one-time payment of $ 8,000,000 .
−Removed: In addition, the Santen Agreements provide
−Removed: for various one-time contingent milestone payments associated with certain manufacturing-related events as well as low-double digit royalty
−Removed: payments on net sales of VERKAZIA and high-single digit royalty payments on net sales of CATIONORM PLUS.
−Removed: Under the Santen Agreements,
−Removed: the Company also assumed certain obligations associated with other third parties that require mid-single digit royalties on sales of
−Removed: FRESHKOTE and ZERVIATE.
−Removed: Immediately following the closing and subject to certain conditions, prior to the transfer of the Santen Products
−Removed: new drug applications (“NDAs”) and other marketing authorizations to the Company, Santen continued to sell the Santen Products
−Removed: on the Company’s behalf and transfer the net profit from the sale of the Santen Products to the Company.
−Removed: See Note 18 regarding
−Removed: the transfer of certain marketing authorizations of the Santen Products.
−Removed: assets acquired in the Santen Products Acquisition are identifiable intangible asset groups in similar asset classes and all directly
−Removed: related to the product NDAs and marketing authorizations acquired.
−Removed: The developed technology is within one major intangible asset class.
−Removed: No workforce/employees were included in the Santen Products Acquisition and the Company is required to utilize its own business inputs/processes
−Removed: to transfer and commercialize the Santen Products.
−Removed: Company incurred $ 139,000 in costs associated with the Santen Products Acquisition, and including such acquisition costs, the payment
−Removed: of $ 8,000,000 at closing and a near term milestone of $ 500,000 .
−Removed: The total purchase price of the Santen Products Acquisition was $ 8,639,000
−Removed: and was accounted for as an asset acquisition.
−Removed: At the time of the Santen Products Acquisition and as of September 30, 2023, the remaining
−Removed: contingent consideration due was not considered probable and reasonably estimable and therefore, no amount was included in the purchase
−Removed: price of the Santen Products Acquisition.
−Removed: At the time the contingent consideration due becomes probable and reasonably estimable the
−Removed: additional consideration, if any, paid will be allocated to all of the assets on a pro rata basis based on their initial estimated fair
−Removed: values as a percent of the total purchase price.
−Removed: of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
−Removed: December 2022, the Company entered into an Asset Purchase Agreement (the “Fab 5 APA”) with Novartis Technology, LLC and Novartis
−Removed: Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive
−Removed: commercial rights to assets associated with the following ophthalmic products (collectively the “Fab 5 Products”) in the
−Removed: (the “Fab 5 Acquisition”):
−Removed: ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE.
−Removed: the terms of the Fab 5 APA, the Company made a one-time payment of $ 130,000,000 at closing in January 2023, with up to another $ 45,000,000
−Removed: due in a milestone payment related to the timing of the commercial availability of TRIESENCE.
−Removed: Pursuant to the Fab 5 APA and various ancillary
−Removed: agreements, immediately following the closing and subject to certain conditions and prior to the transfer of the Fab 5 Products NDAs
−Removed: to the Company, Novartis will continue to sell the Fab 5 Products on the Company’s behalf and transfer the net profit from the
−Removed: sale of the Fab 5 Products to the Company.
−Removed: Novartis has agreed to supply certain Fab 5 Products to the Company for a period of time after
−Removed: the NDAs are transferred and to assist with technology transfer of the Fab 5 Products manufacturing to other third-party manufacturers,
−Removed: assets acquired in the Fab 5 Acquisition are identifiable intangible asset groups in similar asset classes and all directly related to
−Removed: the five product NDAs acquired.
−Removed: The developed technology is within one major intangible asset class.
−Removed: No workforce/employees were included
−Removed: in the Fab 5 Acquisition and the Company is required to utilize its own business inputs/processes to transfer and commercialize the Fab
−Removed: 5 Products and NDAs.
−Removed: Company incurred $ 558,000 in costs associated with the Fab 5 Acquisition and including such acquisition costs and the payment of $ 130,000,000
−Removed: The total purchase price of the Fab 5 Acquisition was $ 130,558,000 and was accounted for as an asset acquisition.
−Removed: time of the Fab 5 Acquisition and as of September 30, 2023, the contingent consideration due related to the commercial availability of
−Removed: TRIESENCE was not considered probable and reasonably estimable and, therefore, no amount was included in the purchase price of the Fab
−Removed: 5 Acquisition.
−Removed: At the time the contingent consideration due related to the commercial availability of TRIESENCE becomes probable and
−Removed: reasonably estimable the additional consideration, if any, paid will be allocated to all of the assets on a pro rata basis based on their
−Removed: initial estimated fair values as a percent of the total purchase price.
−Removed: The Company does not consider any amounts related to TRIESENCE
−Removed: to be in-process research and development (IPR&D) as considered within the scope of ASC 730, Research and Development .
−Removed: of Non-Ophthalmic Assets
−Removed: October 2022, wholly-owned subsidiaries of the Company (collectively, “Imprimis”) entered into an Asset Purchase Agreement
−Removed: (the “RPC Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”).
−Removed: Under the terms of the RPC Agreement,
−Removed: Imprimis agreed to sell substantially all of its assets associated with its non-ophthalmology related compounding product line, including
−Removed: but not limited to, certain intellectual property rights, customer lists, databases, and formulations (the “RPC Assets”).
−Removed: The Buyer agreed to make offers of employment to nine of the Company’s employees that were responsible for the sales activities
−Removed: associated with the RPC Assets.
−Removed: Under the terms of the RPC Agreement, the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000
−Removed: in October 2022.
−Removed: In addition, the Buyer is obligated to pay up to $ 4,500,000 to Imprimis based on mutually agreed upon revenue milestones
−Removed: during the calendar year 2023 (the “Contingent Amount”).
−Removed: During the year ended December 31, 2022, no amount related to the
−Removed: Contingent Amount was recognized by the Company.
−Removed: The Company will recognize a gain related to the Contingent Amount if/when the contingency
−Removed: (in this case, revenue thresholds for 2023) become likely and reasonably estimable.
−Removed: connection with the RPC Agreement, Imprimis entered into a separate transition services agreement (the “RPC TSA”) with the
−Removed: Buyer related to providing ongoing services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing
−Removed: accounting and billing services and collecting accounts receivable.
−Removed: Imprimis provided transition services to the Buyer for approximately
−Removed: nine months following the effective date of the RPC Agreement and expects to wind down transition services in subsequent periods.
−Removed: Company collected and will continue to collect cash on behalf of the Buyer for revenue generated by sales of RPC Assets from October
−Removed: 2022 through the transition period and the Company is obligated to transfer cash generated by such sales to the Buyer.
−Removed: The Company’s
−Removed: condensed consolidated balance sheet as of September 30, 2023 includes accounts receivable of $ 59,000 for cash to be collected on behalf
−Removed: of the Buyer for sales of RPC Assets sold through September 30, 2023.
−Removed: were no amount due from the Buyer for reimbursement of services performed under the RPC TSA as of September 30, 2023.
−Removed: The receivable
−Removed: amount of $ 59,000 was additionally recorded
−Removed: within accrued expenses on the condensed consolidated balance sheet as of September 30, 2023, and represents a payable to the Buyer.
−Removed: The Company recorded a loss from the RPC TSA and disposition and sale of certain related assets and unusable inventory of $ 159,000
−Removed: and $ 330,000 during the three and nine months ended
−Removed: September 30, 2023, respectively, which is presented in other expense, net on the condensed consolidated statements of
+Added: revenue and customer deposits at March 31, 2024 and December 31, 2023 were $ 112,000 and $ 75,000 , respectively.
+Added: All deferred revenue and
+Added: customer deposit amounts at December 31, 2023 were recognized as revenue during the three months ended March 31, 2024.
INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC.
- RELATED PARTY TRANSACTIONS
−Removed: December 2018, the Company entered into an asset purchase agreement (the “Melt APA”) with Melt.
+Added: December 2018, the Company entered into an Asset Purchase Agreement with Melt (the “Melt APA”).
Pursuant to the terms of
3 unchanged sentences
while any patent rights remain outstanding, as well as other conditions.
−Removed: February 2019, the Company entered into a Management Service Agreement with Melt (the “Melt MSA”), whereby the Company provided
−Removed: to Melt certain administrative services and support, including bookkeeping, web services and human resources related activities, and
−Removed: Melt was required to pay the Company a monthly amount of $ 10,000 .
+Added: February 2019, the Company entered into a Management Services Agreement (the “Melt MSA”), whereby the Company provided to
+Added: Melt certain administrative services and support, including bookkeeping, web services and human resources related activities, and Melt
+Added: was required to pay the Company a monthly amount of $ 10,000 .
The Melt MSA was terminated effective July 1, 2023.
−Removed: During the three
−Removed: and nine months ended September 30, 2023 and 2022, the Company recorded $ 0 and $ 89,000 , and $ 30,000 and $ 100,000 , respectively, due from
−Removed: Melt for reimbursable expenses and amounts payable pursuant to the Melt MSA, which are included in prepaid expenses and other current
−Removed: assets in the accompanying condensed consolidated balance sheets.
−Removed: As of September 30, 2023 and December 31, 2022, the Company was due
−Removed: $ 228,000 and $ 139,000 , respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA.
−Removed: The Company made a cash
−Removed: advance to Melt of $ 500,000 and Melt repaid the $ 500,000 cash advance during the nine months ended September 30, 2023.
−Removed: the nine months ended September 30, 2023, Melt sold approximately 2,000,000 shares of its Series B Preferred Stock and raised over $ 17,000,000
−Removed: in gross proceeds from third party investors.
+Added: During the three months
+Added: ended March 31, 2024 and 2023, the Company recorded $ 0 and $ 59,000 , respectively, due from Melt for reimbursable expenses and amounts
+Added: payable pursuant to the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying condensed consolidated
+Added: balance sheets.
+Added: As of March 31, 2024 and December 31, 2023, the Company was due $ 228,000 , from
+Added: Melt for reimbursable expenses and amounts due under the Melt MSA
+Added: March 2024, Melt completed its Series B Preferred Stock financing which raised gross proceeds of approximately $ 23,900,000 .
Company’s Chief Executive Officer, Mark L.
9 unchanged sentences
OF CONDENSED INCOME STATEMENT
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: Revenues, net
−Removed: Loss from operations
−Removed: $ ( 3,663,000 )
−Removed: $ ( 9,064,000 )
−Removed: $ ( 5,407,000 )
−Removed: $ ( 10,562,000 )
+Added: the Three Months Ended
+Added: from operations
unaudited condensed balance sheet information of Melt is summarized below:
OF CONDENSED BALANCE SHEET
−Removed: At September 30,
At December 31,
2 unchanged sentences
Total liabilities
−Removed: Total preferred stock and stockholders’ deficit
−Removed: ( 7,691,000 )
−Removed: ( 18,294,000 )
−Removed: Total liabilities and stockholders’ deficit
−Removed: Note Receivable
−Removed: September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 (the “Melt Loan
−Removed: Agreement”), as lender, with Melt, as borrower.
−Removed: Amounts borrowed under the Melt Loan Agreement bear interest at 12.50 % per annum,
−Removed: which interest can be paid in-kind at the option of Melt until the maturity date.
−Removed: The Melt Loan Agreement permits Melt to pay interest
−Removed: only on the principal amount loaned thereunder through the term and all amounts owed were previously due and payable on September 1,
−Removed: In April 2022, the Company entered into a First Amendment and in September 2022, a Second Amendment (together, the “Amendments”)
−Removed: to the Melt Loan Agreement.
−Removed: The Amendments (i) extended the maturity date of the Melt Loan Agreement to September 1, 2023, which can
−Removed: be extended further to September 1, 2026 upon Melt completing a qualifying financing of a minimum amount of $ 10,000,000 from third-party
−Removed: investors, (ii) added conditions related to minimum cash amounts following a qualifying financing, and (iii) clarified the definition
−Removed: of material adverse effects.
−Removed: Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any
−Removed: time without penalty.
−Removed: has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
−Removed: property rights, to secure the payment of all amounts owed under the Melt Loan Agreement.
−Removed: The Melt Loan Agreement contains customary
−Removed: representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
−Removed: dispositions, investments, distributions, subordinated debt, and transactions with affiliates.
−Removed: The Melt Loan Agreement includes customary
−Removed: events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
−Removed: owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
−Removed: by 3 % per annum.
−Removed: The Melt Loan Agreement is currently in default due to non-payment on September 1, 2023.
−Removed: The Company and Melt are involved
−Removed: in ongoing discussions to resolve the default.
−Removed: connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
−Removed: the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug
−Removed: candidates for a period of five years following the effective date of the Melt Loan Agreement.
−Removed: net funds received by Melt excluded $ 908,000 owed to the Company for reimbursable expenses and amounts due under the Melt MSA prior to
−Removed: the effective date of the note receivable.
−Removed: As of September 30, 2023 and December 31, 2022, aggregate principal and accrued interest payable
−Removed: to the Company pursuant to the Melt Loan Agreement amounted to $ 17,765,000 and $ 15,984,000 , respectively.
−Removed: In accordance with ASC 323,
−Removed: Investments – Equity Method and Joint Ventures , the carrying amount of the note receivable has been reduced by the Company’s
−Removed: allocated share of Melt’s losses based on its ownership of Melt’s total indebtedness (see Note 2).
−Removed: INVESTMENT IN SURFACE OPHTHALMICS, INC.
−Removed: - RELATED PARTY TRANSACTIONS
−Removed: Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (together, the “Surface
−Removed: License Agreements”).
−Removed: Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface certain
−Removed: intellectual property and related rights associated with Surface’s drug candidates (collectively, the “Surface Products”).
−Removed: Surface is required to make mid-single digit royalty payments to the Company on net sales of the Surface Products while any patent rights
−Removed: remain outstanding.
−Removed: of September 30, 2023, the Company owned 3,500,000 shares of Surface common stock.
−Removed: Sternberg, a director of the Company, is
−Removed: a director of Surface.
−Removed: Baum, who is the Company’s Chief Executive Officer, was previously a member of the Surface board
−Removed: of directors and resigned from his position as a director of Surface on March 31, 2023.
−Removed: unaudited condensed results of operations information of Surface is summarized below:
−Removed: OF CONDENSED INCOME STATEMENT
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: Revenues, net
−Removed: Loss from operations
−Removed: $ ( 4,723,000 )
−Removed: $ ( 5,338,000 )
−Removed: $ ( 4,463,000 )
−Removed: $ ( 5,338,000 )
−Removed: unaudited condensed balance sheet information of Surface is summarized below:
−Removed: OF CONDENSED BALANCE SHEET
−Removed: At September 30,
−Removed: At December 31,
−Removed: Current assets
−Removed: Non-current assets
−Removed: Total liabilities
Total preferred stock and stockholders’ equity
2 unchanged sentences
products, including those held at the Company’s 3PL partner, related laboratory supplies and active pharmaceutical ingredients.
−Removed: The composition of inventories as of September 30, 2023 and December 31, 2022 was as follows:
+Added: The composition of inventories as of March 31, 2024
+Added: and December 31, 2023 was as follows:
OF INVENTORIES
−Removed: September 30, 2023
+Added: March 31, 2024
December 31, 2023
4 unchanged sentences
PREPAID EXPENSES AND OTHER CURRENT ASSETS
−Removed: expenses and other current assets at September 30, 2023 and December 31, 2022 consisted of the following:
+Added: expenses and other current assets at March 31, 2024 and December 31, 2023 consisted of the following:
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
−Removed: September 30, 2023
+Added: March 31, 2024
December 31, 2023
1 unchanged sentence
Prepaid computer software licenses and related expenses
−Removed: Due from Melt Pharmaceuticals
Other prepaid expenses
−Removed: Prepaid Prescription Drug User fees
+Added: Receivable due from Melt
+Added: Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees
+Added: Deferred Oaktree Loan commitment fee
Deposits and other current assets
1 unchanged sentence
PROPERTY, PLANT AND EQUIPMENT
−Removed: plant and equipment at September 30, 2023 and December 31, 2022 consisted of the following:
+Added: plant and equipment at March 31, 2024 and December 31, 2023 consisted of the following:
OF PROPERTY, PLANT AND EQUIPMENT
−Removed: September 30, 2023
−Removed: December 31, 2022
−Removed: Property, plant and equipment, net:
−Removed: Computer hardware
−Removed: Furniture and equipment
−Removed: Lab and pharmacy equipment
−Removed: Leasehold improvements
−Removed: Property, plant and equipment,
−Removed: Accumulated depreciation
−Removed: ( 9,804,000 )
+Added: plant and equipment, net:
+Added: and equipment
+Added: and pharmacy equipment
+Added: plant and equipment, gross
( 10,072,000 )
plant and equipment, net
−Removed: the three and nine months ended September 30, 2023, depreciation related to the property, plant and equipment was $ 290,000 and $ 743,000 ,
−Removed: respectively, compared to $ 171,000 and $ 928,000 during the same periods in 2022, respectively.
+Added: the three months ended March 31, 2024 and 2023, depreciation related to the property, plant and equipment was $ 296,000 and $ 225,000 ,
+Added: respectively.
CAPITALIZED SOFTWARE COSTS
−Removed: software costs at September 30, 2023 and December 31, 2022 consisted of the following:
−Removed: OF FINITE LIVED INTANGIBLE ASSETS
−Removed: September 30, 2023
+Added: software costs at March 31, 2024 and December 31, 2023 consisted of the following:
+Added: SCHEDULE OF CAPITALIZED SOFTWARE COSTS
+Added: March 31, 2024
December 31, 2023
5 unchanged sentences
( 1,404,000 )
+Added: ( 1,268,000 )
Capitalized internal-use software in process
−Removed: Total finite lived intangible
−Removed: Company recorded amortization expense of $ 115,000 and $ 352,000 related to capitalized software costs during the three and nine months
−Removed: ended September 30, 2023, respectively, and $ 76,000 and $ 162,000 during the same periods in 2022, respectively.
+Added: Total capitalized software costs net
+Added: the three months ended March 31, 2024 and 2023, the Company recorded amortization expense related to capitalized software costs of $ 136,000
+Added: and $ 67,000 , respectively.
INTANGIBLE ASSETS AND GOODWILL
−Removed: Company’s intangible assets at September 30, 2023 consisted of the following:
−Removed: OF INTANGIBLE ASSETS
+Added: Company’s intangible assets at March 31, 2024 consisted of the following:
+Added: SCHEDULE OF INTANGIBLE ASSETS
Carrying Value
$ ( 169,000 )
−Removed: Acquired NDAs
+Added: Acquired new drug applications (“NDAs”)
( 13,830,000 )
5 unchanged sentences
$ 157,370,000
−Removed: expense for intangible assets for the three and nine months ended September 30, 2023 and 2022 was as follows:
−Removed: OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
+Added: expense for intangible assets for the three months ended March 31, 2024 and 2023 was as follows:
+Added: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: September 30,
Acquired NDAs
1 unchanged sentence
Amortization of intangible
−Removed: future amortization expense for the Company’s intangible assets at September 30, 2023 was as follows:
−Removed: OF ESTIMATED FUTURE AMORTIZATION EXPENSE
−Removed: Remainder of 2023
+Added: future amortization expense for the Company’s intangible assets at March 31, 2024 was as follows:
+Added: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Intangible assets
−Removed: $ 162,435,000
−Removed: were no changes to the carrying value of the Company’s goodwill during the three and nine months ended September 30, 2023 and 2022.
+Added: were no changes to the carrying value of the Company’s goodwill during the three months ended March 31, 2024 and 2023.
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
−Removed: payable and accrued expenses at September 30, 2023 and December 31, 2022 consisted of the following:
−Removed: OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
−Removed: September 30,
−Removed: Accounts payable
−Removed: Income tax payable
−Removed: Accrued insurance premium
−Removed: Accrued IHEEZO milestone payments
−Removed: Accrued litigation settlements
−Removed: Accrued RPC transition payments (see Note 4)
−Removed: Accrued managed care commercial rebates
−Removed: Accrued interest (see Note 13)
−Removed: Accrued exit fee for note payable (see Note 13)
−Removed: Total accounts payable and accrued expenses
+Added: payable and accrued expenses at March 31, 2024 and December 31, 2023 consisted of the following:
+Added: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
+Added: insurance premium
+Added: accrued payments
+Added: interest (see Note 11)
+Added: exit fee for Oaktree Loan (see Note 11)
+Added: accounts payable and accrued expenses
current portion
( 24,581,000 )
−Removed: ( 13,771,000 )
−Removed: Non-current total accrued expenses
−Removed: Company financed all insurance policies for the policy terms of August 17, 2022 through August 16, 2023 and August 17, 2023 through August
−Removed: The financing agreements have an interest rate of 4.13 % and 7.48 % per annum, respectively, and require eight monthly payments
−Removed: of $ 114,000 and nine monthly payments of $ 169,000 , respectively.
+Added: total accrued expenses
+Added: Company financed all insurance policies for the policy term of August 2023 through August 2024.
+Added: The financing agreement has an interest
+Added: rate of 7.48 % per annum and requires nine monthly payments of $ 150,000 , of which we have three payments remaining as of March 31, 2024.
Loan Due 2026
3 unchanged sentences
Upon entering into the Oaktree Loan, the Company drew a principal amount of
−Removed: $ 65,000,000 (“Tranche A”) from the Oaktree Loan and used the net proceeds to repay all amounts owed by the Company pursuant
−Removed: to the Loan and Security Agreement the Company previously entered into with B.
−Removed: Riley Commercial Capital, LLC on December 14, 2022 (the
−Removed: Riley Loan”) – see subheading B.
−Removed: Riley Loan and Security Agreement – Paid in Full within this Note
−Removed: The additional principal loan amount of up to $ 35,000,000 available under the Oaktree Loan (“Tranche B”) will be made
−Removed: available to the Company upon the commercialization of TRIESENCE.
−Removed: If Tranche B is not drawn by the Company on or before March 27, 2024,
−Removed: the amount available under Tranche B will be decreased to $ 30,000,000 .
−Removed: Oaktree Loan is secured by nearly all of the assets, including intellectual property, of the Company and its material subsidiaries.
−Removed: Oaktree Loan has a maturity date of January 19, 2026 and carries an interest rate equal to the Secured Overnight Financing Rate plus
−Removed: 6.5 % per annum (totaling 11.90 % at September 30, 2023).
−Removed: From proceeds, the Company paid fees, and offering expenses, and the Oaktree
−Removed: Loan was issued at an original issue discount of $ 3,415,000 , in aggregate.
−Removed: The Oaktree Loan also carries an exit fee equal to 3.5 % of
−Removed: the aggregate principal amount owed and the Company accrued $ 2,275,000 related to the exit fee.
−Removed: The original issue discount, fees and
−Removed: expenses (including the exit fee) are being amortized over the term of the Oaktree Loan using the effective interest rate method.
−Removed: Oaktree Loan requires quarterly interest-only payments with all of the unpaid principal, interest and fees due on the maturity date,
−Removed: January 19, 2026.
−Removed: July 2023, the Company entered into the First Amendment to Credit Agreement and Guaranty and Consent (the “Oaktree Amendment”)
−Removed: to the Oaktree Loan.
−Removed: Under the Oaktree Amendment, the overall credit facility size was increased from $ 100,000,000 to $ 112,500,000 , and
−Removed: the Company made other changes related to the Santen Products Acquisition (see Note 4).
−Removed: Upon satisfaction of certain conditions to funding,
−Removed: the Company drew down a principal amount of $ 12,500,000 (the “Loan Increase”) to fund the initial one-time payment associated
−Removed: with the Santen Products Acquisition and for other working capital and general corporate purposes.
−Removed: No other material changes to the Oaktree
−Removed: Loan were made pursuant to the Oaktree Amendment.
−Removed: Following entry into the Oaktree Amendment and the funding of the Loan Increase upon
−Removed: closing of the Santen Products Acquisition, the Company has drawn down a total principal loan amount of $ 77,500,000 under the Oaktree
−Removed: Loan and an additional principal loan amount of up to $ 35,000,000 remains available to the Company upon the commercialization of TRIESENCE.
−Removed: The Oaktree Loan exit fee was increased from $ 2,275,000 to $ 2,713,000 pursuant to the Oaktree Amendment.
−Removed: The exit fee is equal to 3.50 %
−Removed: of the amended aggregate principal amount owed and the Company accrued an additional $ 438,000 in the three months ended September 30,
−Removed: 2023 related to the exit fee.
−Removed: Oaktree Loan contains customary guarantees and covenants, including financial covenants related to minimum liquidity and minimum net
−Removed: At September 30, 2023, the Company was in compliance with these covenants.
−Removed: As of the end of the fiscal quarter ending
−Removed: December 31, 2024, if the Company’s Total Leverage Ratio (as defined in the Oaktree Loan) is greater than or equal to five
−Removed: times, but less than seven times, the Company will be required to issue to Oaktree warrants to purchase 375,000
−Removed: shares of the Company’s common stock, and if the Total Leverage Ratio is greater than or equal to seven times, the Company
−Removed: will be required to issue to Oaktree warrants to purchase an additional 375,000
−Removed: shares of the Company’s common stock (equaling 750,000
−Removed: shares in aggregate).
−Removed: If the Total Leverage Ratio as of the end of the fiscal quarter ending December 31, 2024 is less than five
−Removed: times, no warrants will be issued to Oaktree.
−Removed: Based on current projections, the Company does not expect to issue any warrants
−Removed: related to the Oaktree Loan.
−Removed: expense related to the Oaktree Loan totaled $ 2,995,000 and $ 5,660,000 for the three and nine months ended September 30, 2023, respectively,
+Added: $ 65,000,000 .
+Added: In July 2023, the Company drew an additional principal amount of $ 12,500,000 and entered into the First Amendment to the
+Added: Oaktree Loan (the “Oaktree Amendment”).
+Added: Under the Oaktree Amendment, the overall credit facility size was increased from
+Added: $ 100,000,000 to $ 112,500,000 .
+Added: The additional principal loan amount of up to $ 35,000,000 available under the Oaktree Loan (“Tranche
+Added: B”) is made available to the Company upon the commercialization of TRIESENCE.
+Added: Since Tranche B was not drawn by the Company on or
+Added: before March 27, 2024, the amount available under Tranche B decreased to $ 30,000,000 .
+Added: While undrawn, the Company is required to pay a
+Added: commitment fee related to the Tranche B amount equal to 2 % per annum, payable quarterly.
+Added: This fee is recorded within prepaid expenses
+Added: and other current assets and is being amortized on a straight-line basis over the access period.
+Added: expense related to the Oaktree Loan totaled $ 2,953,000 and $ 95,000 for the three months ended March 31, 2024 and 2023, respectively,
and included the amortization of debt issuance costs and discount of $ 603,000 and $ 12,000 , respectively.
– 11.875% Senior Notes Due 2027
−Removed: December 2022 and in January 2023, the Company closed an offering of $ 35,000,000 and $ 5,250,000 , respectively, aggregate principal amount
−Removed: of 11.875 % senior notes due in December 2027 (the “2027 Notes”).
−Removed: The 2027 Notes were sold to investors at a par value of
−Removed: $ 25.00 per 2027 Note, and the offering resulted in net proceeds to the Company of approximately $ 36,699,000 after deducting underwriting
−Removed: discounts and commissions and other offering expenses of $ 3,551,000 .
−Removed: 2027 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s other
−Removed: existing and future senior unsecured and unsubordinated indebtedness.
−Removed: The 2027 Notes are effectively subordinated in right of payment
−Removed: to all of the Company’s existing and future secured indebtedness and structurally subordinated to all existing and future indebtedness
−Removed: of the Company’s subsidiaries, including trade payables.
−Removed: The 2027 Notes bear interest at the rate of 11.875 % per annum.
−Removed: on the 2027 Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on January
−Removed: The 2027 Notes will mature on December 31, 2027 .
−Removed: any time prior to December 31, 2024, the Company may, at its option, redeem the 2027 Notes, in whole at any time or in part from time
−Removed: to time, at a redemption price equal to 100% of the principal amount of the 2027 Notes to be redeemed, plus a make-whole amount, if any,
−Removed: plus accrued and unpaid interest to, but excluding, the date of redemption.
−Removed: The Company may redeem the 2027 Notes for cash in whole or
−Removed: in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note,
−Removed: plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December
−Removed: 31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii)
−Removed: on or after December 31, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
−Removed: to, but excluding, the date of redemption.
−Removed: In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not
−Removed: in part, at the price of $25.50 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, upon occurrence
−Removed: of certain events including the occurrence of a Material Change, as defined in the Second Supplemental Indenture.
−Removed: The 2027 Notes trade
−Removed: on the Nasdaq Stock Market LLC under the symbol “HROWM.”
−Removed: expense related to the 2027 Notes totaled $ 1,375,000 and $ 4,141,000 for the three and nine months ended September 30, 2023, respectively,
−Removed: and included amortization of debt issuance costs and debt discount of $ 180,000 and $ 556,000 , respectively.
−Removed: Chief Executive Officer, Mark L.
−Removed: Baum, Chief Financial Officer, Andrew R.
−Removed: Boll, and former directors R.
−Removed: Lawrence Van Horn and Dr.
−Removed: Lindstrom, in the aggregate, purchased $ 950,000 in principal amount of the 2027 Notes at the time of their offering.
+Added: December 2022 and in January 2023, the Company closed offerings of $ 40,250,000 aggregate principal amount of 11.875 % senior notes due
+Added: December 2027 (the “2027 Notes”).
+Added: Interest expense related to the 2027 Notes totaled
+Added: $ 1,373,000 and $ 1,395,000 for the three months ended March 31, 2024 and 2023, respectively, and included the amortization of debt issuance
+Added: costs and discount of $ 178,000 and $ 200,000 , respectively.
– 8.625% Senior Notes Due 2026
−Removed: April 2021, the Company closed an offering of $ 50,000,000 aggregate principal amount of 8.625 % senior notes due April 2026, and in May
−Removed: 2021 issued an additional $ 5,000,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
−Removed: notes (collectively, the “April Notes”).
−Removed: The April Notes were sold to investors at a par value of $ 25.00 per April Note and
−Removed: the offering resulted in net proceeds to the Company of approximately $ 51,909,000 after deducting underwriting discounts and commissions
−Removed: and other offering expenses of $ 3,091,000 .
−Removed: In September 2021, in a further issuance of the April Notes, the Company sold an additional
−Removed: $ 20,000,000 aggregate principal amount of such notes (the “September Notes,” and together with the April Notes, the “2026
−Removed: Notes”), at a price of $ 25.75 per September Note, with interest of $ 278,000 on the September Notes being accrued from April 20,
−Removed: 2021, the date of issuance of the April Notes.
−Removed: The September offering resulted in net proceeds to the Company of approximately $ 19,164,000
−Removed: after deducting underwriting discounts and commissions and other offering expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 .
−Removed: The September Notes are treated as a single series with the April Notes under the indenture governing the April Notes, dated as of April
−Removed: 20, 2021, and have the same terms as the April Notes (other than the initial offering price and issue date).
−Removed: The 2026 Notes are senior
−Removed: unsecured obligations of the Company and rank equally in right of payment with all of our other existing and future senior unsecured
−Removed: and unsubordinated indebtedness.
−Removed: The 2026 Notes are effectively subordinated in right of payment to all of the Company’s existing
−Removed: and future secured indebtedness and structurally subordinated to all existing and future indebtedness of the Company’s subsidiaries,
−Removed: including trade payables.
−Removed: The 2026 Notes bear interest at a rate of 8.625 % per annum.
−Removed: Interest on the 2026 Notes is payable quarterly
−Removed: in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on July 31, 2021.
−Removed: The 2026 Notes will mature on April
−Removed: The issuance costs were recorded as a debt discount and are being amortized as interest expense, net of the amortization of
−Removed: the premium on note issuance, over the term of the 2026 Notes using the effective interest rate method .
−Removed: to February 1, 2026, the Company may, at its option, redeem the 2026 Notes, in whole at any time or in part from time to time, at a redemption
−Removed: price equal to 100% of the principal amount of the 2026 Notes to be redeemed , plus a make-whole amount, if any, plus accrued and unpaid
−Removed: interest to, but excluding, the date of redemption.
−Removed: The Company may redeem the 2026 Notes for cash in whole or in part at any time at
−Removed: our option on or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid
−Removed: interest to, but excluding, the date of redemption.
−Removed: On and after any redemption date, interest will cease to accrue on the redeemed Notes.
−Removed: The 2026 Notes trade on the Nasdaq Stock Market LLC under the symbol “HROWL”.
−Removed: expense related to the 2026 Notes totaled $ 1,814,000 and $ 5,436,000 and $ 1,814,000 and $ 5,436,000 for the three and nine months ended
−Removed: September 30, 2023 and 2022, respectively, and included amortization of debt issuance costs and discounts of $ 197,000 and $ 585,000 and
−Removed: $ 197,000 and $ 585,000 for three and nine months ended September 30, 2023 and 2022, respectively.
−Removed: Riley Loan and Security Agreement – Paid in Full
−Removed: December 14, 2022 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “BR Loan”)
−Removed: Riley Commercial Capital, LLC, as administrative agent for the lenders.
−Removed: The BR Loan provided for a loan facility of up to $ 100,000,000
−Removed: to the Company with a maturity date of December 14, 2025 (the “Maturity Date”), at an interest rate of 10.875 % per annum.
−Removed: BR Loan was secured by an intellectual property security agreement entered into in connection with the BR Loan, and by all assets of
−Removed: the Company and its material subsidiaries.
−Removed: The outstanding balance of the BR Loan was due in full on the Maturity Date.
−Removed: The BR Loan provided
−Removed: for voluntary prepayment subject to no prepayment fee if no loan amount had been funded or the prepayment or repayment occurred (other
−Removed: than as a result of acceleration of the BR Loan) on or prior to the date that was 90 days following the Effective Date and up to 3.00 %
−Removed: of the amount of the BR Loan based on other payment dates.
−Removed: January 2023, $ 59,750,000 of principal amount was funded pursuant to the BR Loan simultaneously with the consummation of the Fab 5 Acquisition
−Removed: (see Note 4).
−Removed: In March 2023, the Company repaid all amounts owed under the BR Loan, in connection with the Oaktree Loan, and no exit
−Removed: or prepayment fees were paid as a result of the payoff of the BR Loan pursuant to a side letter agreement among the parties.
−Removed: expense related to the BR Loan totaled $ 1,565,000 for the nine months ended September 30, 2023, and included amortization of debt issuance
−Removed: costs and debt discount of $ 356,000 .
−Removed: The Company recorded a loss of $ 5,465,000 related to the early extinguishment of debt associated
−Removed: with the BR Loan.
−Removed: summary of the Company’s debt at September 30, 2023 and December 31, 2022 is described as follows:
−Removed: OF LONG TERM DEBT
−Removed: September 30,
+Added: April and September 2021, the Company closed offerings (including an over-allotment exercise in May 2021) of $ 75,000,000 aggregate principal
+Added: amount of 8.625 % senior notes due April 2026 (the “2026 Notes”).
+Added: In terest expense related
+Added: to the 2026 Notes totaled $ 1,812,000 and $ 1,810,000 for the three months ended March 31, 2024 and 2023, respectively, and included amortization
+Added: of debt issuance costs and debt discount of $ 195,000 and $ 193,000 , respectively.
+Added: summary of the Company’s debt at March 31, 2024 and December 31, 2023 is described as follows:
+Added: SCHEDULE OF LONG TERM DEBT
Senior Notes, due April 2026
Senior Notes, due December 2027
−Removed: Oaktree Loan, due January 2026
+Added: Loan, due January 2026
Notes payable gross
Unamortized debt issuance costs
−Removed: ( 10,564,000 )
−Removed: ( 5,826,000 )
Notes payable net
−Removed: $ 182,186,000
−Removed: $ 104,174,000
−Removed: the three and nine months ended September 30, 2023, the total effective interest rate of the Company’s debt was 10.78 %, and 10.91 %,
−Removed: respectively, and 8.88 % and 8.96 % for the same periods in the prior year, respectively .
−Removed: September 30, 2023, future minimum payments under the Company’s debt were as follows:
−Removed: OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
+Added: the three months ended March 31, 2024 and 2023, the total effective interest rate of the Company’s debt was 10.78 % .
+Added: March 31, 2024, future minimum payments under the Company’s debt were as follows:
+Added: SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Remainder of 2024
9 unchanged sentences
These lease agreements have remaining
−Removed: terms between one to five years and contain various clauses for renewal at the Company’s option.
+Added: terms between one to seven years and contain various clauses for renewal at the Company’s option.
operating lease for 5,789 square feet of office space in Carlsbad, California, which commenced in January 2022 and will expire in
2 unchanged sentences
This includes an amendment, which was made effective July 2020,
−Removed: that extended the term of the original lease and added 1,400 of additional square footage to the lease, and another amendment entered
−Removed: into in May 2021 that extended the term of the lease to July 2027 and added 8,900 square feet of space.
+Added: that extended the term of the original lease and added 1,400 of additional square footage to the lease, another amendment entered
+Added: into in May 2021 that extended the term of the lease to July 2027 and added 8,900 square feet of space, and another amendment entered
+Added: into in January 2024 that added 2,861 square feet of space.
operating lease for 5,500 square feet of office space in Nashville, Tennessee, which commenced in January 2020 and will expire in
December 2024 , with an option to extend the term for two additional five-year periods.
+Added: The Company does not intend to exercise its
+Added: option to extend the term of this lease.
operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee, which commenced in September 2022 and will
expire in September 2027 .
−Removed: September 30, 2023, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
+Added: March 2024, we entered in a new operating lease for 17,625 square feet of office space in Nashville, Tennessee which is expected
+Added: to commence in July 2024 and has a seven year term (target expiration date of June 30, 2032 ) with an option to extend the term for
+Added: two additional five-year terms.
+Added: Once occupied, the Company expects this office space to serve as the Company’s new corporate
+Added: headquarters.
+Added: Any operating lease right-of-use assets and liabilities related to this lease will be recognized at its commencement
+Added: March 31, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.61 % and 11.26 years, respectively.
−Removed: the three and nine months ended September 30, 2023, cash paid for amounts included for the operating lease liabilities was $ 310,000 and
−Removed: $ 921,000 , respectively, and $ 249,000 and $ 622,000 during the same periods in 2022, respectively.
−Removed: During the three and nine months ended
−Removed: September 30, 2023 and 2022, the Company recorded operating lease expense of $ 309,000 and $ 926,000 and $ 309,000 and $ 809,000 , respectively,
−Removed: which is included in selling, general and administrative expenses.
−Removed: lease payments under operating leases as of September 30, 2023 were as follows :
−Removed: OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
+Added: the three months ended March 31, 2024 and 2023, cash paid for amounts included for the operating lease liabilities was $ 327,000 and $ 306,000 ,
+Added: respectively.
+Added: During the three months ended March 31, 2024 and 2023, the Company recorded operating lease expense of $ 319,000 and $ 309,000 ,
+Added: respectively, which is included in selling, general and administrative expenses.
+Added: lease payments under operating leases as of March 31, 2024 were as follows :
+Added: SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating Leases
7 unchanged sentences
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
−Removed: July 2023, the Company closed a public offering of shares of its common stock at an offering price of $ 17.75 per share (the “Offering”).
−Removed: The Company sold 3,887,324 shares of its common stock in the Offering, resulting in the Company receiving aggregate net proceeds of $ 64,520,000 ,
−Removed: after deducting underwriting discounts and commissions and other offering expenses of $ 4,480,000 .
−Removed: July 2023, the Company settled 1,567,913 outstanding PSUs as a result of the achievement of the total stockholder returns (“TSR”)
−Removed: targets set forth in equity incentive awards (the “PSU Agreements”) previously issued to members of the Company’s management
−Removed: team in 2021 (the “2021 Awards”).
−Removed: The 2021 Awards were separated into four tranches and required that the Company achieve
−Removed: and maintain certain levels of TSR ranging from 50 % to 175 % per share during the five-year period following the grant date.
−Removed: TSR was based
−Removed: on the aggregate of:
−Removed: (i) the percent increase of the closing price of the Company’s common stock from July 22, 2021;
−Removed: dividends or like stockholder distributions as specified in the PSU Agreements.
−Removed: In connection with the settlement of the 2021 Awards,
−Removed: an aggregate of 616,984 shares of the Company’s common stock was withheld by Harrow for payroll tax obligations totaling $ 11,273,000 .
−Removed: the nine months ended September 30, 2023, the Company issued 131,760 shares of its common stock underlying RSUs held by a director that
−Removed: ceased providing services to the Company.
−Removed: The RSUs had previously vested, including 13,123 RSUs during the nine months ended September
−Removed: 30, 2023, but the issuance and delivery of the shares were deferred until the director ceased providing services to the Company.
−Removed: the nine months ended September 30, 2023, the Company issued 61,934 shares of common stock and received proceeds of $ 355,000 upon the
−Removed: exercise of options to purchase 61,934 shares of common stock with exercise prices ranging from $ 1.70 to $ 8.50 per share.
−Removed: the nine months ended September 30, 2023, the Company issued 62,367 shares of common stock to Mark L.
−Removed: Baum, the Company’s Chief
−Removed: Executive Officer, upon the cashless exercise of options to purchase 180,000 shares at an exercise price of $ 8.99 per share.
−Removed: withheld from Mr.
−Removed: Baum 77,167 shares as consideration for the cashless exercise and an additional 40,466 shares for payroll tax obligations
−Removed: totaling $ 849,000 .
−Removed: the nine months ended September 30, 2023, the Company issued 55,558 shares of common stock to Andrew R.
−Removed: Boll, the Company’s Chief
−Removed: Financial Officer, upon the cashless exercise of options to purchase 90,000 shares at an exercise price of $ 6.00 per share.
−Removed: withheld from Mr.
−Removed: Boll 25,521 shares as consideration for the cashless exercise and an additional 8,921 shares for payroll tax obligations
−Removed: totaling $ 189,000 .
−Removed: the nine months ended September 30, 2023, upon vesting of 23,000 RSUs granted in January 2020 to Andrew R.
−Removed: Boll, the Company’s
−Removed: Chief Financial Officer, the Company issued 13,398 shares of common stock to Mr.
+Added: the three months ended March 31, 2024, the Company issued 46,175 shares of common stock and received proceeds of $ 348,000 upon the exercise
+Added: of options to purchase 46,175 shares of common stock with exercise prices ranging from $ 6.75 to $ 8.75 per share.
+Added: the three months ended March 31, 2024, 45,000 RSUs granted in February 2021 to Andrew R.
+Added: Boll, the Company’s Chief Financial Officer,
+Added: vested, and 26,520 shares the Company’s common stock were issued to Mr.
Boll, net of 18,480 shares of common stock withheld for
payroll tax withholdings totaling $ 197,000 .
−Removed: the nine months ended September 30, 2023, upon vesting of 88,000 RSUs granted in January 2020 to Mark L.
−Removed: Baum, the Company’s Chief
−Removed: Executive Officer, the Company issued 52,821 shares of common stock to Mr.
−Removed: Baum, net of 35,179 shares of common stock withheld for payroll
−Removed: tax withholdings totaling $ 519,000 .
−Removed: the nine months ended September 30, 2023, 43,130 shares of the Company’s common stock underlying RSUs issued to directors vested,
−Removed: but the issuance and delivery of these shares were deferred until the applicable director ceased providing services to the Company.
+Added: the three months ended March 31, 2024, 150,000 RSUs granted in February 2021 to Mark L.
+Added: Baum, the Company’s Chief Executive Officer,
+Added: vested, and 90,164 shares the Company’s common stock were issued to Mr.
+Added: Baum, net of 59,836 shares of common stock withheld for
+Added: payroll tax withholdings totaling $ 638,000 .
+Added: the three months ended March 31, 2024, 30,000 RSUs granted in February 2021 to John Saharek, the Company’s Chief Commercial Officer,
+Added: vested, and 17,384 shares the Company’s common stock were issued to Mr.
+Added: Saharek, net of 12,616 shares of common stock withheld
+Added: for payroll tax withholdings totaling $ 135,000 .
+Added: the three months ended March 31, 2024, 50,000 RSUs granted in February 2021 to employees, vested, and 32,452 shares the Company’s
+Added: common stock were issued, net of 17,548 shares of common stock withheld for payroll tax withholdings totaling $ 187,000 .
+Added: the three months ended March 31, 2024, 8,389 shares of the Company’s common stock underlying RSUs issued to directors vested, but
+Added: the issuance and delivery of these shares are deferred until the applicable director ceases providing services to the Company.
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
2 unchanged sentences
The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
−Removed: however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
+Added: plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
are otherwise cancelled/forfeited.
−Removed: On September 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
−Removed: 2017 Incentive Stock and Awards Plan which was subsequently amended on September 3, 2021 (as amended, the “2017 Plan” and
−Removed: together with the 2007 Plan, the “Plans”).
−Removed: As of September 30, 2023, the 2017 Plan provided for the issuance of a maximum
−Removed: of 6,000,000 shares of the Company’s common stock.
−Removed: The purposes of the Plans are to attract and retain directors, officers, consultants,
−Removed: advisors and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest
−Removed: of such persons in the Company’s development and financial success.
−Removed: Under the Plans, the Company is authorized to issue incentive
−Removed: stock options intended to qualify under Section 422 of the IRC of 1986, as amended, non-qualified stock options, restricted stock units,
−Removed: performance stock units and restricted stock.
−Removed: The Plans are administered by the Compensation Committee of the Company’s Board of
−Removed: The Company had 490,493 shares available for future issuances under the 2017 Plan at September 30, 2023 .
−Removed: summary of stock option activity under the Plans for the nine months ended September 30, 2023 is as follows:
−Removed: OF STOCK OPTION PLAN ACTIVITY
+Added: On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
+Added: 2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
+Added: with the 2007 Plan, the “Plans”).
+Added: As of December 31, 2023, the 2017 Plan provides for the issuance of a maximum of 6,000,000
+Added: shares of the Company’s common stock.
+Added: The purpose of the Plans are to attract and retain directors, officers, consultants, advisors
+Added: and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
+Added: persons in the Company’s development and financial success.
+Added: Under the Plans, the Company is authorized to issue incentive stock
+Added: options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted
+Added: stock units and restricted stock.
+Added: The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
+Added: The Company had 400,250 shares available for future issuances under the 2017 Plan at March 31, 2024.
+Added: summary of stock option activity under the Plans for the three months ended March 31, 2024 is as follows:
+Added: SCHEDULE OF STOCK OPTION PLAN ACTIVITY
Number of Shares
−Removed: Weighted Average
+Added: Weighted Average Exercise Price
Weighted Average Remaining Contractual Life
−Removed: Aggregate Intrinsic
+Added: Aggregate Intrinsic Value
Options outstanding – January 1, 2024
2 unchanged sentences
Options cancelled/forfeited
−Removed: Options outstanding – September 30, 2023
+Added: Options outstanding – March 31, 2024
Options exercisable
2 unchanged sentences
have been received by option holders if all option holders had exercised and immediately sold all shares underlying options with an exercise
−Removed: price lower than the market price on September 30, 2023, based on the closing price of the Company’s common stock of $ 14.37 on
−Removed: the nine months ended September 30, 2023, the Company granted stock options to certain employees.
−Removed: The stock options were granted with
−Removed: an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which
+Added: price lower than the market price on March 31, 2024, based on the closing price of the Company’s common stock of $ 13.23 on that
+Added: the three months ended March 31, 2024, the Company granted stock options to certain employees.
+Added: The stock options were granted with an
+Added: exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which
the common stock was then listed, at the grant date and have contractual terms of ten years.
Vesting terms for options granted to employees
−Removed: during the nine months ended September 30, 2023 included the following vesting schedule:
−Removed: 25% of the shares subject to the option vest
−Removed: and become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest and
−Removed: become exercisable quarterly in equal installments thereafter over three years.
−Removed: Certain option awards provide for accelerated vesting
−Removed: if there is a change in control (as defined in the Plans) and in the event of certain modifications to the option award agreement.
+Added: during the three months ended March 31, 2024 included the following vesting schedule:
+Added: 25% of the shares subject to the option vest and
+Added: become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest and become
+Added: exercisable quarterly in equal installments thereafter over three years.
+Added: Certain option awards provide for accelerated vesting if there
+Added: is a change in control (as defined in the Plans) and in the event of certain modifications to the option award agreement.
fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model.
19 unchanged sentences
4.06 - 4.21 %
−Removed: 1.54 - 3.19 %
Dividend yield
−Removed: following table summarizes information about stock options outstanding and exercisable at September 30, 2023:
−Removed: SCHEDULE OF STOCK
−Removed: OPTION OUTSTANDING AND EXERCISABLE
+Added: following table summarizes information about stock options outstanding and exercisable at March 31, 2024:
+Added: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Options Outstanding
10 unchanged sentences
$ 1.47 - $ 25.86
−Removed: of September 30, 2023, there was approximately $ 1,781,000 of total unrecognized compensation expense related to unvested stock options
−Removed: granted under the Plans.
+Added: of March 31, 2024, there was approximately $ 1,815,000 of total unrecognized compensation expense related to unvested stock options granted
+Added: under the Plans.
That expense is expected to be recognized over the weighted-average remaining vesting period of 2.81 years.
−Removed: The stock-based compensation for all stock options was $ 154,000 and $ 617,000 during the three and nine months ended September 30, 2023,
−Removed: respectively, and $ 241,000 and $ 771,000 during the same periods in 2022, respectively.
−Removed: intrinsic value of options exercised during the nine months ended September 30, 2023 was $ 4,399,000 .
+Added: The stock-based
+Added: compensation for all stock options was $ 126,000 and $ 341,000 during the three months ended March 31, 2024 and 2023, respectively.
+Added: intrinsic value of options exercised during the three months ended March 31, 2024 was $ 139,000 .
awards are granted subject to certain vesting requirements and other restrictions, including time-based performance and market-based
2 unchanged sentences
common stock on the grant date, is expensed over the vesting period of the RSUs.
−Removed: the nine months ended September 30, 2023, the Company’s board of directors were granted an aggregate 41,301 time-based vesting
−Removed: RSUs with a fair market value of $ 800,000 , which vest in equal quarterly installments over one year.
−Removed: summary of the Company’s RSU activity and related information for the nine months ended September 30, 2023 is as follows:
−Removed: OF RESTRICTED STOCK UNITS ACTIVITY
+Added: summary of the Company’s RSU activity and related information for the three months ended March 31, 2024 is as follows:
+Added: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number of Shares
2 unchanged sentences
RSUs cancelled/forfeited
−Removed: RSUs unvested - September 30, 2023
−Removed: of September 30, 2023, the total unrecognized compensation expense related to unvested RSUs was approximately $ 1,041,000 , which is expected
+Added: RSUs unvested - March 31, 2024
+Added: of March 31, 2024, the total unrecognized compensation expense related to unvested RSUs was approximately $ 859,000 , which is expected
to be recognized over a weighted-average period of 2.2 years, based on estimated and actual vesting schedules of the applicable RSUs.
−Removed: The stock-based compensation for RSUs during the three and nine months ended September 30, 2023 was $ 374,000 and $ 789,000 , respectively,
−Removed: and $ 427,000 and $ 1,378,000 during the same periods in 2022, respectively.
−Removed: April 2023, the Company granted an aggregate of 1,567,913 PSUs to members of its senior management including Mark Baum, Chief Executive
−Removed: Officer, Andrew Boll, Chief Financial Officer, and John Saharek, Chief Commercial Officer, which are subject to the satisfaction of certain
−Removed: market-based and continued service conditions (the “2023 PSUs”).
−Removed: The vesting of the 2023 PSUs require (i) a minimum of a
−Removed: two-year service period, and (ii) during a five-year term, the achievement and maintenance of Company common stock price targets ranging
−Removed: between $ 25.00 to $ 50.00 per share, separated into four separate tranches as described further in the table below.
−Removed: OF PERFORMANCE STOCK UNITS
−Removed: Number of Shares
−Removed: Target Share Price*
−Removed: Share Price assumes that no dividends or like distributions are made to stockholders of the Company.
−Removed: If such distributions are made,
−Removed: the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a
−Removed: part of the Target Share Price.
−Removed: aggregate fair value of the 2023 PSUs was $ 29,106,000 using a Monte Carlo Simulation with a five-year life, 65 % volatility and a risk
−Removed: free interest rate of 10.34 %.
−Removed: This amount is being amortized over a two-year derived service period.
−Removed: summary of the Company’s PSU activity and related information for the nine months ended September 30, 2023 is as follows:
−Removed: OF PERFORMANCE STOCK UNITS ACTIVITY
+Added: The stock-based compensation for RSUs during the three months ended March 31, 2024 and 2023 was $ 405,000 and $ 29,000 , respectively.
+Added: summary of the Company’s PSU activity and related information for the three months ended March 31, 2024 is as follows:
+Added: SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY
Number of Shares
1 unchanged sentence
PSUs unvested – January 1, 2024
−Removed: ( 1,567,913 )
PSUs cancelled/forfeited
−Removed: PSUs unvested – September 30, 2023
−Removed: of September 30, 2023, the total unrecognized compensation expense related to unvested PSUs was approximately $ 21,829,000 , which is expected
+Added: PSUs unvested – March 31, 2024
+Added: of March 31, 2024, the total unrecognized compensation expense related to unvested PSUs was approximately $ 14,553,000 , which is expected
to be recognized over a weighted-average period of 1.01 years, based on estimated and actual vesting schedules of the applicable PSUs.
−Removed: The stock-based compensation for PSUs during the three and nine months ended September 30, 2023 was $ 3,948,000 and $ 10,115,000 , respectively,
−Removed: and $ 1,264,000 and $ 3,792,000 during the same periods in 2022, respectively.
+Added: The stock-based compensation for PSUs during the three months ended March 31, 2024 and 2023 was $ 3,638,000 and $ 1,263,000 , respectively.
Compensation Summary
Company recorded stock-based compensation related to equity instruments granted to employees, directors and consultants as follows:
−Removed: OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
−Removed: For the Three Months Ended September 30,
−Removed: For the Nine Months Ended September 30,
+Added: SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES, DIRECTORS AND CONSULTANTS
+Added: For the Three Months Ended March 31,
Employees - selling, general and administrative
30 unchanged sentences
damages from the other.
−Removed: The Company expects the trial to take place in 2024.
+Added: The Company expects the trial to take place in August 2024.
and Professional Liability
3 unchanged sentences
given time reflects current market conditions, including cost and availability, when the policy is written.
−Removed: addition to the indemnification provisions contained in the Company’s governing documents, the Company generally enters into separate
+Added: addition to the indemnification provisions contained in the Company’s charter documents, the Company generally enters into separate
indemnification agreements with each of the Company’s directors and officers.
5 unchanged sentences
individual with respect to which the individual may be entitled to indemnification by the Company.
−Removed: The Company indemnifies Oaktree for
−Removed: certain claims and losses associated with the Oaktree Loan.
−Removed: The Company also indemnifies its lessors in connection with its facility
−Removed: leases for certain claims arising from the use of the facilities.
−Removed: These indemnities do not provide for any limitation of the maximum
−Removed: potential future payments the Company could be obligated to make.
−Removed: Historically, the Company has not incurred any payments for these obligations
−Removed: and, therefore, no liabilities have been recorded for these indemnities in the accompanying condensed consolidated balance sheets.
−Removed: License Agreement – Related Party
−Removed: Company entered into a license agreement in April 2017, as amended in April 2018 (the “Klarity License Agreement”), with
−Removed: Lindstrom, M.D., a former member of its Board of Directors.
−Removed: Pursuant to the terms of the Klarity License Agreement, the Company
−Removed: licensed certain intellectual property and related rights from Dr.
−Removed: Lindstrom to develop, formulate, make, sell, and sub-license the topical
−Removed: ophthalmic solution Klarity designed to protect and rehabilitate the ocular surface (the “Klarity Product”).
−Removed: the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr.
−Removed: Lindstrom ranging from 3% to 6% of
−Removed: net sales, dependent upon the final formulation of the Klarity Product sold.
−Removed: In addition, the Company is required to make certain milestone
−Removed: payments to Dr.
−Removed: Lindstrom including:
−Removed: (i) an initial payment of $ 50,000 upon execution of the Klarity License Agreement, (ii) a second
−Removed: payment of $ 50,000 following the first $ 50,000 in net sales of the Klarity Product;
−Removed: and (iii) a final payment of $ 50,000 following the
−Removed: first $ 100,000 in net sales of the Klarity Product.
−Removed: All of the above referenced milestone payments were payable at the Company’s
−Removed: election in cash or shares of the Company’s restricted common stock.
−Removed: Payments totaling $ 0 and $ 146,000 were made during the three
−Removed: and nine months ended September 30, 2023, respectively, compared to $ 77,000 and $ 199,000 during the same periods in 2022, respectively.
−Removed: Royalty expenses were $ 71,000 and $ 220,000 during the three and nine months ended September 30, 2023, respectively, compared to $ 67,000
−Removed: and $ 244,000 during the same periods in 2022, respectively, and were included in accounts payable to Dr.
−Removed: Asset Purchase Agreement – Related Party
−Removed: December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr.
−Removed: Lindstrom, a former member
−Removed: of its Board of Directors.
−Removed: Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and related
−Removed: rights from Dr.
−Removed: Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom Product”).
−Removed: the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr.
−Removed: Lindstrom ranging from 2% to 3% of net sales,
−Removed: dependent upon the final formulation and patent protection of the Lindstrom Product sold .
−Removed: In addition, the Company is required to make
−Removed: certain milestone payments to Dr.
−Removed: Lindstrom including an initial payment of $ 33,000 that was due upon execution of the Lindstrom APA.
−Removed: Lindstrom was paid $ 0 and $ 17,000 in cash during the three and nine months ended September 30, 2023, respectively, and $ 8,000 and
−Removed: $ 23,000 during the same periods in 2022, respectively.
−Removed: The Company incurred $ 9,000 and $ 26,000 for royalty expenses related to the Lindstrom
−Removed: APA during the three and nine months ended September 30, 2023, respectively, and $ 9,000 and $ 24,000 during the same periods in 2022,
−Removed: respectively.
−Removed: Asset Purchase, License and Related Agreements
−Removed: Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors and related
−Removed: parties (the “Inventors”) through multiple asset purchase agreements, license agreements, strategic agreements and commission
−Removed: In general, these agreements provide that the Inventors will cooperate with the Company in obtaining patent protection for
−Removed: the acquired intellectual property and that the Company will use commercially reasonable efforts to research, develop and commercialize
−Removed: a product based on the acquired intellectual property.
−Removed: In addition, the Company has acquired a right of first refusal on additional intellectual
−Removed: property and drug development opportunities presented by these Inventors.
−Removed: consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors based
+Added: Several of the Company’s asset
+Added: purchase and license agreements contain customary representations, warranties, covenants and confidentiality provisions, and also contain
+Added: mutual indemnification obligations related primarily to performance under the respective agreements.
+Added: The Company also indemnifies its
+Added: lessors in connection with its facility leases for certain claims arising from the use of the facilities.
+Added: These indemnities do not provide
+Added: for any limitation of the maximum potential future payments the Company could be obligated to make.
+Added: Historically, the Company has not
+Added: incurred any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying
+Added: condensed consolidated balance sheets.
+Added: Purchase, License and Related Agreements
+Added: Approved Product Acquisitions
+Added: recent years, the Company has acquired commercial and product rights to various FDA approved ophthalmic medications and products through
+Added: asset purchase, licenses, supply and/or other related agreements.
+Added: In general, in exchange for product and commercial rights these agreements
+Added: provide the counterparties with certain upfront and contingent milestone payments typically related to certain annual sales amounts and
+Added: manufacturing events, and in certain cases, per unit transfer prices and royalties on sales of some of the products.
+Added: During the three
+Added: months ended March 31, 2024 and 2023, $ 274,000 and $ 0 were incurred under these agreements as royalty expenses, respectively.
+Added: Company incurred $ 0 and $ 5,000,000 related to upfront and milestone payments under these agreements during the three months ended March 31,
+Added: 2024 and 2023, respectively.
+Added: As of March 31, 2024, the remaining contingent consideration payable pursuant to these agreements were not
+Added: considered probable and reasonably estimable and therefore, no amount was accrued related to these contingent obligations during the
+Added: three months ended March 31, 2024.
+Added: At the time contingent consideration payable becomes probable and reasonably estimable the additional
+Added: consideration, if any, paid will be allocated to the assets based on their initial estimated fair values as a percent of the total purchase
+Added: Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors, innovator
+Added: companies and related parties (the “Inventors”) through multiple asset purchase agreements and license agreements.
+Added: these agreements provide that the Inventors will cooperate with the Company in obtaining patent protection for the acquired intellectual
+Added: property and that the Company will use commercially reasonable efforts to research, develop and commercialize a product based on the
+Added: acquired intellectual property.
+Added: In addition, the Company has acquired a right of first refusal on additional intellectual property and
+Added: drug development opportunities presented by these Inventors.
+Added: consideration for the acquisition of these intellectual property rights, the Company is obligated to make payments to the Inventors based
on the completion of certain milestones, generally consisting of:
−Removed: (1) a payment payable within 30 days after the issuance of the first
−Removed: patent in the United States arising from the acquired intellectual property (if any);
−Removed: (2) a payment payable within 30 days after the
−Removed: Company files the first investigational new drug application (“IND”) with the U.S.
−Removed: Food and Drug Administration (“FDA”)
−Removed: for the first product arising from the acquired intellectual property (if any);
−Removed: (3) for certain of the Inventors, a payment payable within
−Removed: 30 days after the Company files the first new drug application with the FDA for the first product arising from the acquired intellectual
−Removed: property (if any);
−Removed: and (4) certain royalty payments based on the net receipts received by the Company in connection with the sale or
−Removed: licensing of any product based on the acquired intellectual property (if any), after deducting (among other things) the Company’s
−Removed: development costs associated with such product.
−Removed: If, following five years after the date of the applicable asset purchase agreement, the
−Removed: Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated a study where
−Removed: data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired intellectual property,
−Removed: the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign the acquired technology to
−Removed: the Inventors.
−Removed: During the three and nine months ended September 30, 2023, $ 220,000 and $ 705,000 were incurred under these agreements
−Removed: as royalty expenses, respectively, and $ 185,000 and $ 695,000 during the same periods in 2022, respectively.
−Removed: July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A.
−Removed: (“Sintetica”),
−Removed: pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
−Removed: (“IHEEZO”) in the U.S.
−Removed: to the Sintetica Agreement, the Company agreed to pay Sintetica a per unit transfer price to supply IHEEZO, along with a per unit royalty
−Removed: for units sold.
−Removed: The Company is required to pay Sintetica up to $ 18,000,000 in one-time milestone payments including a $ 5,000,000 payment
−Removed: (the “Upfront Payment”) that was due within 30 days of signing the Sintetica Agreement and the balance of payments due upon
−Removed: achievement of certain regulatory and commercial milestones.
−Removed: Under the terms of the Sintetica Agreement, Sintetica was responsible for
−Removed: regulatory filings for IHEEZO in the U.S.
−Removed: As of September 30, 2023, the Company had paid all milestone amounts due under the Sintetica
−Removed: Agreement, and all commercial milestones were previously capitalized as an intangible asset.
−Removed: August 2023, the Company amended the Sintetica Agreement to allow for early payment of previously accrued amounts for commercial related
−Removed: milestones associated with sales of IHEEZO in exchange for a $ 550,000 reduction in the milestone amounts due, and as a result of this
−Removed: amendment, the Company reduced the intangible asset value associated with IHEEZO by $ 550,000 and paid the remaining commercial milestone
−Removed: amount of $ 4,450,000 during the three and nine months ended September 30, 2023.
−Removed: to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds
−Removed: August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
−Removed: with Wakamoto Pharmaceutical Co., Ltd.
−Removed: (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
−Removed: and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S.
−Removed: to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company will pay Wakamoto a per unit transfer price
−Removed: to supply MAQ-100.
−Removed: In addition, the Company is required to pay Wakamoto various one-time milestone payments totaling up to $ 2,000,000
−Removed: upon the achievement of certain regulatory milestones and up to $ 6,200,000 upon the achievement of certain commercial milestones.
−Removed: the terms of the Wakamoto Agreements, the Company will be responsible for regulatory filings and fees for MAQ-100 in the U.S.
−Removed: Through September 30, 2023, no amounts have been paid or accrued under the Wakamoto Agreements.
−Removed: to certain limitations, the term of the Wakamoto Agreements is for five years from the date of the FDA’s market approval of MAQ-100
−Removed: and may be extended for a five-year period if certain unit sales thresholds are met.
−Removed: Commercial Alliance Agreement – Terminated
−Removed: August 2020, the Company, through its wholly owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
−Removed: Agreement”) with Eyepoint Pharmaceuticals, Inc.
−Removed: (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
−Removed: right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% (“DEXYCU”) for the treatment of post-operative
−Removed: inflammation following ocular surgery in the United States.
−Removed: Pursuant to the Dexycu Agreement, Eyepoint pays the Company a fee calculated
−Removed: based on the quarterly sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S.
−Removed: Under the terms
−Removed: of the Dexycu Agreement, the Company agreed to use commercially reasonable efforts to promote and market DEXYCU in the U.S.
−Removed: to a mutual termination agreement entered into on October 7, 2022, the Dexycu Agreement terminated on January 1, 2023.
−Removed: Following the
−Removed: preliminary Hospital Outpatient Prospective Payment System (HOPPS) rule proposed by the Centers for Medicare & Medicaid Services
−Removed: (CMS) in July of 2022, which did not contain an extension of the pass-through payment period for DEXYCU beyond December 31, 2022, the
−Removed: Company entered into a Mutual Termination Agreement (the “Termination Agreement”) with Eyepoint on October 7, 2022, pursuant
−Removed: to which Eyepoint and the Company agreed (a) that the Company would continue to support the sale of DEXYCU through the fourth quarter
−Removed: of 2022, consistent with the Company’s level of effort during the January through September 2022 period, (b) to decrease the required
−Removed: minimum quarterly sales levels based on DEXYCU unit demand for the fourth quarter of 2022, and (c) to terminate the Dexycu Agreement,
−Removed: along with ancillary letter agreements, effective January 1, 2023.
−Removed: the three and nine months ended September 30, 2022, the Company recorded $ 1,044,000 and $ 3,576,000 , respectively, in commission revenues
−Removed: related to the Dexycu Agreement.
+Added: (1) a payment payable within 30 to 45 days after the issuance
+Added: of the first patent in the United States arising from the acquired intellectual property (if any);
+Added: (2) a payment payable within 30 days
+Added: after the Company files the first investigational new drug application (“IND”) with the U.S.
+Added: Food and Drug Administration
+Added: (“FDA”) for the first product arising from the acquired intellectual property (if any);
+Added: (3) for certain of the Inventors,
+Added: a payment payable within 30 days after the Company files the first new drug application with the FDA for the first product arising from
+Added: the acquired intellectual property (if any);
+Added: and (4) certain royalty payments based on the net receipts received by the Company in connection
+Added: with the sale or licensing of any product based on the acquired intellectual property (if any), after deducting (among other things)
+Added: the Company’s development costs associated with such product.
+Added: If, following five years after the date of the applicable asset purchase
+Added: agreement, the Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated
+Added: a study where data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired
+Added: intellectual property, the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign the
+Added: acquired technology to the Inventors.
+Added: During the three months ended March 31, 2024 and 2023, $ 180,000 and $ 376,000 were incurred under
+Added: these agreements as royalty expenses, respectively.
and Marketing Agreements
9 unchanged sentences
Commission expenses of $ 0 and $ 130,000 were incurred under these agreements for commission
−Removed: expenses during the three and nine months ended September 30, 2023, respectively, and $ 1,041,000 and $ 3,188,000 during the same periods
−Removed: in 2022, respectively.
+Added: expenses during the three months ended March 31, 2024 and 2023, respectively.
+Added: Manufacturing
+Added: Company had entered into manufacturing agreements with respect to third-party contract manufacturers for its FDA approved pharmaceutical
+Added: Some of these contract manufacturing agreements require minimum annual order amounts.
+Added: The Company has committed to pay approximately
+Added: $ 2,728,000 related to contract manufacturing agreements for the year ending December 31, 2024.
SEGMENTS AND CONCENTRATIONS
3 unchanged sentences
the Company as a single operating segment.
−Removed: Company has two products that each accounted for more than 10% of total revenues during the three and nine months ended September
−Removed: The Company had two and three products that each accounted for more than 10% of total revenues during the three and nine
−Removed: months ended September 30, 2022, respectively.
−Removed: These products collectively accounted for 32 %
−Removed: of revenues during the three and nine months ended September 30, 2023, respectively, and 34 %
−Removed: during the same periods in 2022, respectively.
−Removed: of September 30, 2023 and December 31, 2022, accounts receivable from a single customer accounted for 48 % and 0 % of total accounts receivable,
+Added: Company had one and two products that accounted for more than 10% of total revenues during the three months ended March 31, 2024 and
2023, respectively.
−Removed: For the three and nine months ended September 30, 2023, revenues from a single customer accounted for 35 % and 23 % of total
−Removed: revenues, respectively.
−Removed: For the three and nine months ended September 30, 2022, no customer exceeded 10% of total revenues.
+Added: These products accounted for 11 % and 36 % of revenues during the three months ended March 31, 2024 and 2023, respectively.
+Added: of March 31, 2024 and December 31, 2023, accounts receivable from a single customer accounted for 68 % and 80 % of total accounts receivable,
+Added: respectively.
+Added: For the three months ended March 31, 2024, revenues from a single customer accounted for 27 % of total revenues.
+Added: three months ended March 31, 2023, no customer exceeded 10% of total revenues.
Company receives its active pharmaceutical ingredients from three main suppliers.
−Removed: These suppliers collectively accounted for 96 % and
−Removed: 79 % of active pharmaceutical ingredient purchases during the three and nine months ended September 30, 2023, respectively, and 52 % and
−Removed: 66 % during the same periods in 2022, respectively.
+Added: These suppliers collectively accounted for 85 % of active
+Added: pharmaceutical ingredient purchases during the three months ended March 31, 2024, and 90 % during the same period in 2023.
SUBSEQUENT EVENTS
−Removed: Company has performed an evaluation of events occurring subsequent to September 30, 2023 through the filing date of this Quarterly Report
+Added: Company has performed an evaluation of events occurring subsequent to March 31, 2024 through the filing date of this Quarterly Report
on Form 10-Q.
Based on its evaluation, no events other than those described below need to be disclosed.
−Removed: November 2023, the Company issued 125 shares of common stock and received proceeds of $ 1,000 upon the exercise of options to purchase
−Removed: 125 shares of common stock with exercise price of $ 6.75 per share.
−Removed: October 2023, the Company transferred the NDAs and marketing authorizations for all of the Santen Products in the U.S.
−Removed: The Company expects
−Removed: Santen to transfer the Canadian marketing authorizations for VERKAZIA and CATIONORM PLUS by March 31, 2024.
+Added: April 2024, the Company issued 1,481 shares of common stock and received proceeds of $ 11,000 upon the exercise of options to purchase
+Added: 1,481 shares of common stock with exercise prices between $ 10.62 and $ 12.72 per share.
+Added: April 2024, the Company sold all 1,982,000 shares of common stock it held of Eton in a block trade at a gross price of $ 3.00 per share.
+Added: After deducting trading expenses and commissions of approximately $ 436,000 , the Company received net proceeds of $ 5,510,000 related to
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.